Process for enrobing a core

ABSTRACT

A process for enrobing a core, such as a tablet core, uses a coating that is made of a patterned film having portions that are visually distinct (e.g, differently colored) from one another and having a transition line segment between these visually distinct portions. At least a portion of an outer surface of the core is covered with the film, such that the transition line segment forms a substantially continuous transition line on the coating and such that a film seam is formed which is different from the transition line. Alternatively, the coating is formed from two such patterned films, in which case the outer surface of the core is covered with the two films such that the two transition line segments cooperate to form a substantially continuous transition line on the coating and a film seam is formed which is different from the transition line. Prior to covering the outer surface of the core, the two films may be oriented such that the resulting enrobed core has a bi-colored coating with two visually distinct portions each lying on opposite sides of the transition line of the coating. The two films may also be oriented such that the resulting enrobed core has four alternately arranged colored portions, two of which are of a first color and the other two of which are of a second color, thereby resulting in a “checkerboard” effect.

FIELD OF THE INVENTION

The present invention relates to a process for enrobing a core, such asa tablet core, with at least one patterned film to produce an enrobedcore having a patterned coating.

BACKGROUND OF THE INVENTION

Various oral dosage forms have been developed over the years forpharmaceuticals and dietary supplements. Among the more popular oraldosage forms are tablets, capsules and, most recently, gelcaps. Tabletsare compressed or molded solid dosage forms of any size or shape. Solid,generally oblong-shaped tablets may sometimes be referred to as caplets.Tablets remain popular with consumers, however uncoated tablets sufferfrom drawbacks such as medicinal taste, a tendency to powder or flake(i.e., physical disintegration) when packaged in bottles, and/or theperception by consumers that they are not easy to swallow. Theselimitations are eliminated by coating the tablets with a polymericcoating.

During most of the 20th century, hard gelatin capsules were a populardosage form for prescription and over-the-counter (OTC) drugs. Capsulesare hard shell compartments made of two halves, including a body and acap, wherein the cap partially and snugly overlaps with the body toenclose a dosable drug ingredient therein. The enclosed dosableingredient is most often is a powder, liquid, paste or similar nonsolidform.

Generally, empty hard shell capsules are produced by a conventionaldip-molding process such as that which is described on page 182 of“Pharmaceutical Dosage Forms and Drug Delivery Systems, 7^(th) Ed.”,(1999) by Howard C. Ansel, Loyd V. Allen Jr., and Nicholas G. Popovich,published by Lippincott Williams & Wilkins, Baltimore, Md. Consumershave found that such capsules are aesthetically pleasing, easy toswallow and mask the medicine taste of the drug contained therein. Inaddition, the bodies and caps of such capsules are often produced indifferent colors, resulting in a bi-colored capsule product havingenhanced aesthetic appeal, as well as improved product identificationand brand recognition by consumers. Many patients preferred capsulesover coated or uncoated tablets, prompting pharmaceutical manufacturersto market certain products in capsule form even when they were alsoavailable in tablet form. However, due to potential tampering concerns,capsules are no longer a preferred delivery choice for consumer (i.e.,over-the-counter) pharmaceuticals.

One alternative to capsule products are caplets, which are solid, oblongtablets that are often coated with various polymers such as celluloseethers to improve their aesthetics, stability, and swallowability.Typically, such polymers are applied to the tablets either from solutionin organic solvents, or from aqueous dispersion via spraying. Stillother methods involve spray coating tablets with a gelatin coatingsolution. See, e.g., U.S. Pat. Nos. 4,973,480 and 6,113,945. However,such spray-coated tablets lack the glossy surface and elegance of thehard gelatin capsules. Additionally, it is not commercially feasible tospray-coat a tablet with a different color coating on each end.

Another alternative to capsule products are “gelcaps,” which areelegant, consumer-preferred dosage forms comprising solid tabletscovered with a glossy gelatinous coating. Currently, gelcaps are amongthe most popular oral dosage forms. Several methods of producing gelcapshave been developed in an effort to provide tamper-proof capsule-likeproducts. One category of such methods involve dipping tablets, one halfat a time, into gelatin coating solutions, which can be of two differentcolors, see, e.g., U.S. Pat. No. 4,820,524, or dipping tablets of afirst color halfway into a into gelatin coating solution of a secondcolor, see, e.g., U.S. Pat. No. 6,113,945. Another category of suchmethods involves shrink-fitting the capsule halves onto a tablet form.See, for example, U.S. Pat. Nos. 5,415,868, 6,126,767, 5,464,631,5,460,824, 5,317,849, 5,511,361, 5,609,010, 5,795,588 and 6,080,426, andInternational Patent Appln. Publication No. WO 97/37629. Another methodinvolves sealing the body and cap of the capsule at the overlapping seamtherebetween. See U.S. Pat. No. 5,824,338. Another method of producinggelcaps is via an enrobing process wherein two separate films made ofgelatinous material are applied to opposite sides of a tablet by a pairof rotary dies. A detailed description of this process is provided, forexample, in U.S. Pat. Nos. 5,146,730 and 5,459,983, and the entirecontents and disclosures of both of these patents are herebyincorporated herein by reference.

Briefly, in the aforesaid rotary die process, two circular dies eachhaving a circumferential surface are positioned such that the surfacesare in abutting relationship with one another, thereby forming a niptherebetween. Each of the dies have a series of matching recesses ontheir circumferential surfaces. As the dies rotate, the films are joinedand fused together, at the nip between the dies where a pair of matchingrecesses form a pocket into which a tablet is dropped by a metered feedmechanism. As the dies continue to rotate, the tablet urges the filmsinto the interior of the recesses in the dies, and the tablet is therebysecurely enveloped and enrobed by the films, while the films continue tobe joined and fused together about the tablet by the dies.Simultaneously with the fusing of the films about the tablet, theenrobed tablet is pinch-cut from the films by the rotary dies, whereuponit separates from the films in the form of an individual enrobed tablet.If the films used are of two different colors, the resulting enrobedtablets are bi-colored having a color transition line that iscommensurate with the seam between the films. Thus, while foregoingprocess produces tamper-proof bi-colored enrobed tablets, the colortransition of such products will always be commensurate with the seambetween the films.

Each of the foregoing methods for producing tamper-proof coated tabletssuffer from several shortcomings, including uneven color of the capsulehalves and/or coatings, uneven thickness of the capsule halves and/orcoatings, and the creation of raised seams between capsule halves and/orcoatings. In addition, the bi-colored products resulting from theaforesaid methods have a line defined by the color transition, which isalways the same as the line defined by the seam between the capsulehalves and/or coatings.

U.S. Pat. No. 5,672,300 discloses the production and use of striped andpatterned films with the foregoing rotary die process to producepatterned enrobed tablets. The striped films disclosed therein areproduced by depositing stock film forming material of a first color froma first spreader box to form a base film and then, using a secondspreader box, adding stripes of a differently colored stock materialonto the base film. Films having different patterns, including stripesand/or marbleized, are created by oscillating the second spreader boxrelative to the first spreader box. The gelcaps produced by this processhave multiple stripes, or a marbleized pattern, rather than simply beingbi-colored (i.e., one half being one color and the other half being asecond color). Films prepared by this process suffer from the limitationof having multiple layers, with increased total film thickness in thearea where the second film material is applied. The increased filmthickness creates an uneven appearance and feel to the surface, andretards dissolution, which is undesirable for immediate release dosageforms. Thus, there is still a need to produce bi-colored enrobed tabletsthat are enrobed with films according to the rotary die process and thathave color transitions that are not commensurate with the seam betweenthe films.

SUMMARY OF THE INVENTION

The present invention relates to a process for enrobing a core, such asa tablet core, using a coating that is made of a patterned film havingportions that are visually distinct (e.g., differently colored) from oneanother and having a transition line segment between such visuallydistinct portions. More particularly, at least a portion of an outersurface of the core is covered with the patterned film, such that thetransition line segment forms a substantially continuous transition lineon the coating and such that a film seam is formed which is differentfrom the transition line. That is, the film seam lies substantially in afirst reference plane that passes through the core, while the transitionline segment lies substantially in a second reference plane that passesthrough the core and intersects the first reference plane.

Alternatively, the coating is formed from two films, each of which hasportions that are visually distinct from one another and a transitionline segment between such visually distinct portions. The outer surfaceof the core is covered with the two films such that the two transitionline segments cooperate to form a substantially continuous transitionline on the coating and a film seam is formed on the coating which isdifferent from the transition line. Like when a single film is used, thefilm seam lies substantially in the first reference plane that passesthrough the core, while the transition line segment lies substantiallyin the second reference plane that passes through the core andintersects the first reference plane.

By using bi-colored films and orienting the films appropriately withreference to the core and each other, the resulting enrobed core can bebi-colored with the film seam of the coating lying substantially in thefirst reference plane and the transition line between the two colorsthereof lying substantially in the second reference plane. In addition,the resulting enrobed core can instead have four alternately is arrangedcolored portions, two of which are of a first color and the other two ofwhich are of a second color, thereby resulting in a “checkerboard”effect.

Where the portions of each of the two films are all visually distinctfrom one another and the films are properly oriented with reference tothe core and each other, the resulting enrobed core can have a coatingwith at least four portions each having a different visual distinction(e.g., color). The film seam of the coating would still liesubstantially in the first reference plane and the transition line wouldstill be different from the film seam and would still lie substantiallyin the second reference plane.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the present invention, reference is madeto the following detailed description of several exemplary embodimentsconsidered in conjunction with the accompanying drawings, in which:

FIG. 1A is an enlarged, schematic top plan view of an oblong convex coreof a first configuration, the bottom plan view being identical thereto;

FIG. 1B is an enlarged, schematic elevational side view of the oblongconvex core of FIG. 1A, the opposite elevational side view beingidentical thereto;

FIG. 2 is an enlarged, schematic elevational end view of the oblongconvex core of FIGS. 1A and 1B, the opposite elevational end view beingidentical thereto;

FIG. 3 is an enlarged, schematic elevational side view of an oblongconvex core of a second configuration, the opposite elevational sideview, as well as the top and bottom plan views, being identical thereto;

FIG. 4 is an enlarged, schematic elevational end view of the oblongconvex core of FIG. 3, the opposite elevational end view being identicalthereto;

FIG. 5 is an enlarged, schematic top plan view of a round convex core,the bottom plan view being identical thereto;

FIG. 6 is an enlarged, schematic elevational front view of the roundconvex core of FIG. 5, the elevational back view, as well as bothelevational side views, being identical thereto;

FIG. 7A is an enlarged, schematic top plan view of a round flat corewith beveled edges, the schematic bottom plan view being identicalthereto;

FIG. 7B is an enlarged, schematic elevational front view of the roundflat core of FIG. 7A, the elevational back view, as well as bothelevational side views, being identical thereto;

FIG. 8A is an enlarged, schematic top plan view of an oval convex core,the schematic bottom plan view being identical thereto;

FIG. 8B is an enlarged, schematic elevational front view of the ovalconvex core of FIG. 8A, the elevational back view being identicalthereto;

FIG. 9 is a simplified, schematic elevational front view of film castingapparatus in accordance with a first embodiment of the presentinvention;

FIG. 10 is a simplified, schematic top plan view of the film castingapparatus of FIG. 9, showing the interior chambers of the slit extruder;

FIG. 11 is a simplified, schematic elevational left side view of thefilm casting apparatus of FIG. 9, looking in the direction of arrow A;

FIG. 12 is an elevational left side view of one of the partitions thatis positioned within the slit extruder;

FIG. 13 is a perspective view of the interior roller, partitions andslidable gate of the slit extruder of FIGS. 9-11;

FIG. 14 is a simplified, schematic elevational front view of theenrobing apparatus, including the film-casting apparatus of FIGS. 9-13,in accordance with the first embodiment of the present invention;

FIG. 15 is a top plan view of a portion of two overlapped striped filmswith cores placed therebetween, showing the proper orientation of thecores in relation to the stripes on the films;

FIG. 16 is a simplified perspective view of the rotating die and stripedfilms, as well as enrobed cores produced thereby, in accordance with thefirst embodiment of the present invention;

FIG. 17 is a simplified, schematic elevational side view of analternative film casting apparatus in accordance with a secondembodiment of the present invention;

FIG. 18 is a simplified, schematic top plan view of the alternative filmcasting apparatus of FIG. 17, showing the interior chambers of thereciprocating slit extruder;

FIG. 19 a simplified, schematic elevational front view of thealternative film casting apparatus of FIG. 18, as viewed from theposition of line G—G and looking in the direction of the arrows;

FIG. 20 is a simplified perspective view of the rotating die and stripedfilms, as well as enrobed cores produced thereby, in accordance with thesecond embodiment of the present invention;

FIG. 21 is a top plan view of a portion of two overlapped striped filmswith cores placed therebetween, showing the proper orientation of thecores in relation to the stripes on the films;

FIG. 22 is a simplified, schematic elevational side view of a coredispensing means that is part of an alternative core enrobing apparatusin accordance with a third embodiment of the present invention;

FIG. 23 is a schematic perspective view of the core positioning slatshown in FIG. 22;

FIGS. 24A-24C are simplified, schematic elevational front views of thecore positioning slat, core plunger, film and cores, as viewed from theposition of line Q—Q in FIG. 22 and looking in the direction of thearrows, showing the operation of the core plunger to position cores ontothe film;

FIG. 25A is a simplified, schematic elevational side view of the corepositioning slat, core plunger, film, and cores, shown in FIG. 24A;

FIG. 25B is a simplified, schematic elevational side view of the corepositioning slat, core plunger, film, and cores, shown in FIG. 24B;

FIG. 25C is a simplified, schematic elevational side view of the corepositioning slat, core plunger, film, and cores, shown in FIG. 24C;

FIG. 26 is a simplified, schematic perspective view of the conveyorsystem and the rotary die of the third embodiment of the presentinvention, as well as the enrobed core products produced thereby;

FIG. 27 is a simplified, schematic elevational view of a single rollerof the conveyor system, the film and a core positioned thereon, as seenfrom the position of line T—T in FIG. 26 and looking on the direction ofthe arrows, showing the horizontal orientation of the roller;

FIG. 28 is a simplified, schematic elevational view of a first pair ofrollers of the conveyor system, the film and a core positioned thereon,as seen from the position of line V—V in FIG. 26 and looking on thedirection of the arrows, showing the slightly angled orientation of therollers;

FIG. 29 is a simplified, schematic elevational view of a second pair ofrollers of the conveyor system, the film and a core positioned thereon,as seen from the position of line X—X in FIG. 26 and looking on thedirection of the arrows, showing the substantially angled orientation ofthe rollers;

FIG. 30 is a simplified, schematic elevational view of a third pair ofrollers of the conveyor system, the film and a core positioned thereon,as seen from the position of line Z—Z in FIG. 26 and looking on thedirection of the arrows, showing the different configuration of theserollers and their vertical orientation;

FIG. 31 is a schematic elevational side view of the apparatus of thefourth embodiment;

FIG. 32 is a schematic perspective view of a tranversely-striped filmsuitable for use with a porous platen having a plurality of recessesarranged in rows;

FIG. 33 is a schematic perspective view of a porous platen having aplurality of recesses arranged in rows and suitable for use with thetransversely-striped a film of FIG. 32;

FIG. 34 is a schematic perspective view of a longitudinally-striped filmis suitable for use with a porous platen having a plurality of recessesarranged in rows;

FIG. 35 is a schematic perspective view of a porous platen having aplurality of recesses arranged in rows and suitable for use with thelongitudinally-striped film of FIG. 34;

FIG. 36 is a partial, schematic, cross-sectional elevational side viewof a first station of the apparatus of the fourth embodiment, with thenear cross-sectional half cut away therefrom, showing how the film isheated and vacuum formed about one half of the core;

FIG. 37 is a partial, schematic, cross-sectional elevational side viewof a second station of the apparatus of the fourth embodiment, with thenear cross-sectional half cut away therefrom, showing how the film iscooled and molded about one half of the core;

FIG. 38 is a partial, schematic, cross-sectional elevational side viewof a third station of the apparatus of the fourth embodiment, with thenear cross-sectional half cut away therefrom, showing how the film iscut away from the perimeter of the partially enrobed core;

FIG. 39 is a partial, schematic, cross-sectional elevational side viewof a fourth station of the apparatus of the fourth embodiment, with thenear cross-sectional half cut away therefrom, showing how the partiallyenrobed core thereon is positioned beneath an inverted porous platen fortransfer thereto;

FIG. 40 is a partial, schematic, cross-sectional elevational side viewof the fourth station of FIG. 39, showing how the inverted porous platenis lowered onto the partially enrobed core and how the two platens andpartially enrobed core are subsequently rotated together;

FIG. 41 is a partial, schematic, cross-sectional elevational side viewof a fifth station of the apparatus of the fourth embodiment, with thenear cross-sectional half cut away therefrom, showing how a second filmis heated and vacuum formed about the uncovered portion of the core;

FIG. 42 is a partial, schematic, cross-sectional elevational side viewof a sixth station of the apparatus of the fourth embodiment, with thenear cross-sectional half cut away therefrom, showing how the secondfilm is cooled and molded about the core;

FIG. 43 is a partial, schematic, cross-sectional elevational side viewof a seventh station of the apparatus of the fourth embodiment, with thenear cross-sectional half cut away therefrom, showing how the secondfilm is cut away from the perimeter of the fully enrobed core; and

FIG. 44 is a partial, schematic, cross-sectional elevational side viewof the apparatus of the fourth embodiment after it has been moved awayfrom the seventh station, showing the fully enrobed core as it is beingrelease from the apparatus.

DETAILED DESCRIPTION OF THE INVENTION

As used hereinafter, “core” shall mean a solid dosage form of any sizeor shape. Suitable cores include compressed or molded tablets, hard andsoft capsules, confectionery based forms such as for example lozenges,nougats, or fondants, and the like. Cores are available in variousshapes and configurations. For example, FIGS. 1A, 1B and 2 show anoblong convex core 10 which has an oblong shape and two rounded ends 12,14, as viewed from the top, bottom or sides (see FIGS. 1A and 1B). Theoblong convex core 10 may also have two oppositely positioned convexsurfaces 15, 15′ and a raised portion therebetween, referred to as aland 20 (shown most clearly in FIGS. 1B and 2).

It is noted that the length of the oblong core 10 is an imaginary line(not shown per se, but which is commensurate with a portion of thedotted line 16 that is within the core 10 shown in FIG. 1B) whichextends the distance between the ends 12, 14 of the oblong core 10. Theheight of the oblong core 10 is another imaginary line (not shown perse, but which is commensurate with a portion of the dotted line 18 thatis within the core 10 shown in FIG. 1B) which extends the distancebetween the two opposite convex surfaces 15, 15′ of the core 10, midwayof the length. The width of the oblong core is a third imaginary line(not shown per se, but which is commensurate with a portion of thedotted line 16 that is within the core 10 shown in FIG. 2) which extendsthe distance between opposite sides of the core 10, perpendicular to andmidway of the core's length and height (and which may intersect the land20 of the core 10, if present).

To facilitate discussion hereinafter of the position of the films andcolor transitions that are applied to the enrobed core products, certainreference planes will now be defined in relation to the core 10 and itslength, height and width. It is noted that while a number of differentreferences planes may be defined in relation to the oblong core 10, themethods, apparatus and products of the present invention will bediscussed primarily in terms of certain orthogonal planes of symmetry,as follows.

With reference to FIGS. 1B and 2, as used hereinafter, the “transverse”,or “major”, plane of symmetry 16 of the core 10 is the reference planewhich includes the length and width of the core 10 and which isperpendicular to and substantially bisects is the height of the core 10.The land 20 of the core 10, if present, may be aligned with thetransverse plane of symmetry 16 (see FIGS. 1B and 2) such that the land20 is substantially bisected along its entire length. As shown in FIG.1B, it is noted that a portion of the core 10 which lies on one side ofthe transverse plane of symmetry 16 is substantially a mirror image ofthe remaining portion of the core 10 which lies on the opposite side ofthe transverse plane of symmetry 16.

With reference to FIGS. 1A and 1B, as used hereinafter, the “conjugate”,or “minor” plane of symmetry 18 of the oblong core 10 is the referenceplane which includes the width and height of the core 10 and which isperpendicular to and substantially bisects the length of the core 10. Aswith the transverse plane of symmetry 16, a portion of the core 10 whichlies on one side of the conjugate plane of symmetry 18 is substantiallya mirror image of the other side of the core 10 which lies on theopposite side of the conjugate plane of symmetry 18.

With reference now to FIGS. 1A and 2, a third plane of symmetry 17includes the length and height of the core 10 and is perpendicular toand substantially bisects the width of the core 10. As with thetransverse and conjugate planes of symmetry 16, 18, respectively, aportion of the core 10 which lies on one side of the third plane ofsymmetry 17 is substantially a mirror image of the other side of thecore 10 which lies on the opposite side of the third plane of symmetry17.

It is noted that additional reference planes can be defined, includingmany which are not planes of symmetry. For example, a reference plane 19(see FIG. 1B) may be defined that is parallel to the length and width ofthe core 10, but does not include the length or width and does notdivide the core into mirror image portions. In addition, anotherreference plane 21 (see FIG. 2) could be defined such that it isparallel to the length of the core 10, perpendicular to both the widthand height of the core 10, but does not include any of the length, widthor height of the core and does not divide the core into mirror imageportions. It will be understood by a person having ordinary skill in theart that many additional possibilities exist for defining referenceplanes in relation to the core 10. However, the remaining description ofthe method, apparatus and products of the present invention will bediscussed using, primarily, the transverse and conjugate planes ofsymmetry 16, 18, respectively.

With reference now to FIGS. 3-8A, examples are provided of cores havingshapes and configurations different from the oblong convex core 10 shownin FIGS. 1A, 1B and 2. More particularly, as shown in FIGS. 3 and 4, anoblong convex core 10 a may, alternatively, have a central cylindricalsubsection 22 between the two rounded ends 12 a, 14 a (i.e., instead ofa land 20). The core 10 a shown in FIGS. 3 and 4 includes a transverseplane of symmetry 16 a and a conjugate plane of symmetry 18 a, theorientation of which are defined in the same manner as provided above inconnection with the oblong core 10 of FIGS. 1A, 1B and 2. As can be seenfrom FIGS. 3 and 4, the rounded ends 12,′ 14′ of the caplet 10′ are ofslightly smaller diameter than the cylindrical subsection 20.

FIGS. 5, 6, 7A and 7B provide examples of “round” cores, which are coreshaving a generally round or circular configuration when viewed fromabove (see the top views shown in FIGS. 5 and 7A). In addition, whileround cores have a length, a width and a height, the length and width ofeach round core are dimensionally interchangeable due to the generallycircular configuration of each round core.

With reference in particular to FIGS. 5 and 6, a “round convex” core 24may have two oppositely positioned convex surfaces 25, 25′ which areseen most clearly from a front, back or side elevational view, such asprovided in FIG. 6. The round convex core 24 includes a transverse planeof symmetry 26 and a conjugate plane of symmetry 28, the orientation ofwhich are defined in the same manner as provided above in connectionwith the oblong core 10 of FIGS. 1A, 1B and 2. As also seen most clearlyin FIG. 6, the round convex core 24 may also have a raised portion, orland 20′, similar to the land 20 of the oblong convex core 10 of FIGS.1A, 1B and 2.

With reference now to FIGS. 7A and 7B, a “round flat” core 24 a may havetwo oppositely positioned flat surfaces 25 a, 25 a′ (i.e., rather thanconvex surfaces). The round flat core 24 a may also have a beveled edge27 a positioned 27 a proximate to one flat surface 25 a (see FIGS. 7Aand 7B) and another beveled edge 27 a′ positioned proximate to the otherflat surface 25 a′ (see FIG. 7B) of the round flat core 24 a. The roundflat core 24 a includes a transverse plane of symmetry 26 a and aconjugate plane of symmetry 28 a, the orientation of which are definedin the same manner as provided above in connection with the oblong core10 of FIGS. 1A, 1B and 2.

FIGS. 8A and 8B provide one example of a type of “oval” core 24 b.Generally, “oval” cores are cores having have a generally ovalconfiguration when viewed from above (see, for example, the top viewshown in FIG. 8A). An “oval convex” core 24 b, shown in FIGS. 8A and 8B,may have two oppositely positioned convex surfaces 25 b, 25 b′ which areseen most clearly from a front, back or side elevational view, such asprovided in FIG. 8B. The oval convex core 24 b includes a transverseplane of symmetry 26 b and a conjugate plane of symmetry 28 b, theorientation of which are defined in the same manner as provided above inconnection with the oblong core 10 of FIGS. 1A, 1B and 2. As seen mostclearly in FIG. 8B, the oval convex core 24 b may also have a raisedportion, or land 20 b′, similar to the land 20 of the oblong convex core10 of FIGS. 1A, 1B and 2.

It is noted that, while the present invention has applicability to coredosage forms of various shapes, including but not limited to the shapesshown in FIGS. 1A-8B, the remaining drawing figures and the detaileddescription provided hereinafter show and discuss the apparatus andmethods of the present invention as applied to the oblong convex caplet10 of the first configuration exemplified in FIGS. 1A, 1B and 2. It isunderstood, however, that the present invention may also be applied todifferently shaped cores, including, but not limited to, the cores ofother configurations, including oblong, round and oval cores, shown inFIGS. 3-8B.

The product of the present invention, which is produced by the methodsand apparatus of the present invention described hereinafter, is anenrobed substrate (also referred to herein as a “core”). Such enrobedproducts are often referred to as “geltabs” or “gelcaps”. The terms“geltabs” and “gelcaps” shall mean a substrate having at least one,non-core layer, or film, made of a film forming or gel forming substanceor substances. The substrate, or core may be a compressed tablet, orother non-liquid (e.g., solid or semi-solid) dosage form.

More particularly, as will be described in further detail hereinafter,the enrobed core of the present invention is enrobed by at least onefilm having at least two visually distinct portions (i.e., at least twoportions having different visual appearances) and at least one visualtransition line between the visually distinct portions of the film. Itis noted that, hereinafter, the apparatus and method of the presentinvention are discussed as producing enrobed cores that aresubstantially enrobed by the film or films and the term “substantially”shall be understood to mean that at least about 95% of the surface areaof the core is covered by the film or films. Furthermore, it will beunderstood by those having ordinary skill in the art that the apparatusand method of the present invention may be adapted to produce enrobedcore products that are at least partially covered by the film or films.The term “at least partially covered” shall be understood to mean thatat least about 25% to about 100% of the surface area of the core iscovered by the film or films.

It is further noted that the visually distinct portions of the patternedfilm or films may be of different colors, hues, glosses, reflectivequalities, brightness, depth, shades, chroma, opacity, etc. Patternedfilms may also be embossed or etched with surface relief patterns fortextural and visual effects, as in the case of a holographic image orpattern. For example, the patterned film could have at least twoportions having different visual appearances as follows: a red portionand a yellow portion (such as red and yellow stripes, or a redbackground having yellow spots thereon), or a flat finish portion and aglossy portion, or an opaque portion and a translucent portion. Whilethe apparatus and methods of the present invention will be discussedhereinafter as employing films that have differently colored stripes(i.e., red and yellow stripes) with a color transition linetherebetween, it will be understood that the patterned films may haveany of the foregoing types of visually distinct portions, orcombinations thereof, including visual distinctions not specificallymentioned herein.

It is further noted that the films of the present invention may be madeof any elastic, plastic material (i.e., stock film forming material)that is preferably pharmaceutically acceptable and which is, or can bemade, semi-liquid and flowable to facilitate the formation of apatterned, seamless and continuous film that can be made formable andmalleable and which has smooth and controllable transition lines betweenthe visually distinct portions thereof. More particularly, the films ofthe present invention may be formed of various materials, including, butnot limited to, compositions comprising, consisting of, and/orconsisting essentially of a film former; optionally a thickener;optionally an extender, optionally a plasticizer, and optionally variousadjuvants and excipients.

Any film former known in the art is suitable for use in film compositionof the present invention. Examples of suitable film forming materialsinclude, but are not limited to, cellulosics such as methylcellulose,hydroxypropylcellulose (HPC), hydroxyethylmethylcellulose (HEMC),hydroxypropylmethylcellulose (HPMC), hydroxybutylmethylcellulose (HBMC),hydroxyethylethylcellulose (HEEC), and hydroxyethylhydroxypropylmethylcellulose (HEMPMC); modified starches such as cross-linked starches,chemically modified starches including hydroxypropyl starch,hydroxyethyl starch, methylethyl starch, carboxymethyl starch; andphysically modified starches including pre-gelatinized starches;proteins such as gelatin, whey protein, egg albumin, casein and caseinisolates, soy protein and soy protein isolates; and other film-formingpolymers such as polyvinylalcohol (PVA), methacrylic acid andmethacrylate ester copolymers, polyvinyl alcohol and polyethylene glycolcopolymers, and derivatives and mixtures thereof.

One suitable hydroxypropylmethylcellulose compound is “HPMC 2910”, whichis a cellulose ether having a degree of substitution of about 1.9 and ahydroxypropyl molar substitution of 0.23, and containing, based upon thetotal weight of the compound, from about 29% to about 30% methoxyl andfrom about 7% to about 12% hydroxylpropyl groups. HPMC 2910 iscommercially available from the Dow Chemical Company under thetradename, “METHOCEL E.” “METHOCEL E5,” which is one grade of HPMC-2910suitable for use in the present invention, has a viscosity of about 4 to6 cps (4 to 6 millipascal-seconds) at 20 degrees Celsius in a 2% aqueoussolution as determined by a Ubbelohde viscometer. Similarly, “METHOCELE6,” which is another grade of HPMC-2910 suitable for use in the presentinvention, has a viscosity of about 5 to 7 cps (i.e., 5 to 7millipascal-seconds) at 20 degrees Celsius in a 2% aqueous solution asdetermined by a Ubbelohde viscometer. “METHOCEL E 15,” which is anothergrade of HPMC-2910 suitable for use in the present invention, has aviscosity of about 15000 cps (15 millipascal-seconds) at 20 degreesCelsius in a 2% aqueous solution as determined by a Ubbelohdeviscometer. As used herein, “degree of substitution” shall mean theaverage number of substituent groups attached to a anhydroglucose ring,and “hydroxypropyl molar substitution” shall mean the number of moles ofhydroxypropyl per mole anhydroglucose.

One suitable polyvinyl alcohol and polyethylene glycol copolymer iscommercially available from BASF Corporation under the tradename“KOLLICOAT IR”.

As used herein, “modified starches” include starches that have beenmodified by crosslinking, chemically modified for improved stability oroptimized performance, or physically modified for improved solubilityproperties or optimized performance. Chemically modified starches havetypically been treated with chemicals so that some hydroxyl groups havebeen replaced by either ester or ether groups. Very low levels ofchemical modification can significantly change the rheological,physical, and chemical properties of starch. Crosslinking, in which twohydroxyl groups on neighboring starch molecules are linked chemically isalso a form of chemical modification. As used herein, “pre-gelatinizedstarches” or “instantized starches” refers to physically modifiedstarches that have been pre-wetted, then dried to enhance theircold-water solubility. Acid-hydrolyzed starch is a term used for astarch suspension treated with dilute acid at a temperature below thegelatinization point. The granular form of the starch is maintained andthe reaction is ended by neutralization, filtration and drying once thedesired degree of conversion is reached. This results in a reduction inthe average molecular size of the starch polymers. Acid-hydrolyzedstarches tend to have a lower hot viscosity than native starch and astrong tendency to gel when cooled. Suitable modified starches arecommercially available from several suppliers such as, for example, A.E.Staley Manufacturing Company, and National Starch & Chemical Company.

One suitable modified starch includes the pre-gelatinized waxy maizederivative starches that are commercially available from National Starch& Chemical Company under the tradenames, “PURITY GUM” and “FILMSET”, andderivatives, copolymers, and mixtures thereof. Such waxy maize starchestypically contain, based upon the total weight of the starch, from about0% to about 18% of amylose and from about 100% to about 88% ofamylopectin.

Another suitable modified starch includes the hydroxypropylatedstarches. These are starches in which some of the hydroxyl groups havebeen etherified with hydroxypropyl groups, usually by treatment withpropylene oxide. These starches are characterized by having excellentrefrigeration and freeze/thaw stability. Hydroxypropyl food starches aregenerally crosslinked in addition to the etherification. Hydroxypropyldistarch phosphate is a starch used widely in the food industry in whichboth monofunctional hydroxypropyl groups have been added in combinationwith phosphate crosslinking. One example of a suitable hydroxypropylstarch is commercially available from Grain Processing Company under thetradename, “PURE-COTE B790”.

Suitable tapioca dextrins include those available from National Starch &Chemical Company under the tradenames “CRYSTAL GUM” or “K-4484”, andderivatives thereof such as modified food starch derived from tapioca,which is available from National Starch and Chemical Company under thetradename “PURITY GUM 40”, and copolymers and mixtures thereof.

Any thickener known in the art is suitable for use in the filmcomposition of the present invention. Examples of such thickenersinclude but are not limited to hydrocolloids such as alginates, agar,guar gum, locust bean gum, kappa carrageenan, iota carrageenan, tara,gum arabic, tragacanth, pectin, xanthan gum, gellan gum, maltodextrin,galactomannan, pusstulan, laminarin, scleroglucan, gum arabic, inulin,pectin, whelan, rhamsan, zooglan, methylan, chitin, cyclodextrin,chitosan, clays, acid hydrolyzed starches and derivatives and mixturesthereof. Additional suitable thickeners include sucrose, dextrose,fructose, and the like, and derivatives and combinations thereof.

Suitable xanthan gums include those available from C.P. Kelco Companyunder the tradename, “KELTROL 1000,” “XANTROL 180,” or “K9B310.”

Suitable clays include smectites such as bentonite, kaolin, andlaponite; magnesium trisilicate, magnesium aluminum silicate, and thelike, and derivatives and mixtures thereof. The smectites are a group ofminerals that swell as they absorb water or organic molecules within thestructural layers; they also have considerable cationic exchangeproperties.

Suitable acid hydrolyzed starches include that commercially availablefrom Grain Processing Corporation under the tradename, “PURE-SET B950”,and hydroxypropyl distarch phosphates such as that commerciallyavailable from Grain Processing Corporation under the tradename,“PURE-GEL B990”.

Suitable extenders include malotdextrin and polydextrose and mixturesand derivatives thereof.

Any plasticizer known in the pharmaceutical art is suitable for use inthe present invention, and may include, but not be limited topolyethylene glycol; glycerin; sugar alcohols; triethyl citrate; tribuylcitrate; dibutyl sebecate; vegetable oils such as castor oil;surfactants such as polysorbates, sodium lauryl sulfates, anddioctyl-sodium sulfosuccinates; propylene glycol; mono acetate ofglycerol; diacetate of glycerol; % triacetate of glycerol; natural gumsand mixtures thereof. Suitable sugar-alcohols include sorbitol,mannitol, xylitol, maltitol, erythritol, lactitol, and mixtures thereof.In solutions containing a cellulose ether film former, an optionalplasticizer may be present in an amount, based upon the total weight ofthe solution, from about 0% to about 40%.

Other suitable film materials include the gelatin-based materialdisclosed in U.S. Pat. Nos. 5,146,730 and 5,459,983, as well as othermaterials discussed therein that include, but are not limited to,polymers, such as polyvinyl chloride and polyvinyl pyrrolidone.

In one embodiment, the film composition contains, based upon the totaldry solids weight of the composition, from about 95% to less than about100%, e.g. from about 95% to about 99.5%, of a film former such as acellulose ether, e.g., hydroxypropylmethylcellulose; and optionally fromabout 0.5% to about 5% of a thickener such as a hydrocolloid, e.g.,xanthan gum; and optionally, from about 0.1% to about 1.0%, e.g. fromabout 0.25% to about 0.5% of a plasticizer such as vegetable oils, e.g.castor oil.

In an embodiment wherein the film forming agent is a thermoplasticstarch, the film composition may include from about 60% to about 90%thermoplastic starch, about 0.5% to about 10% plasticizers, about 0% toabout 40% hydrophilic extenders such as gelatin and about 0% to about 5%release aids such as fats or waxes. The formulation of such embodimentsis described in further detail in U.S. Pat. Nos. 5,427,614 and4,673,438. The portions of U.S. Pat. Nos. 5,427,614 and 4,673,438 whichdisclose the formulations and the methods of producing such formulationsare hereby incorporated herein by reference.

In another embodiment, wherein the film forming agent is a celluloseeither, such as hydroxypropylmethylcellulose (HPMC), the filmcomposition may include about 70% to about 90%hydroxypropylmethylcellulose (HPMC), about 5% to about 20% plasticizers,such as glycerine or polyethylene glycol, about 0.5% to about 2.5% waterand about 1% to about 20% hydrophilic extenders such as gelatin. Theformulation of such embodiments is described in further detail in U.S.Pat. Nos. 4,655,840 and 4,790,881. The portions of U.S. Pat. Nos.4,655,840 and 4,790,881 which disclose the formulations and the methodsof producing such formulations are hereby incorporated herein byreference.

In a further embodiment, wherein the film forming agent is a chemicallymodified starch, the thickener may be selected from the group consistingof kappa or iota carrageenan, maltodextrin, gellan gum, agar, thinboiling starch, hydroxypropyl distarch phosphate and derivatives andmixtures thereof.

In another embodiment, wherein the film forming agent is a chemicallymodified starch, the plasticizer may be selected from the groupconsisting of glycerin, propylene glycol, polyethylene glycol, sugaralcohols and derivatives and mixtures thereof.

Optionally, the composition may further comprise other ingredients suchas, based upon the total weight of the formulation, from about 0% toabout 2% preservatives such as methylparaben and propylparaben, fromabout 0% to about 14% opacifying agents such as titanium dioxide, and/orfrom about 0% to about 14% colorants. See Remingfon's Practice ofPharmacy, Martin & Cook, 17^(th) ed., pp. 1625-30, which is hereinincorporated by reference.

Any coloring agent suitable for use in pharmaceutical applications maybe used in the present invention and may include, but not be limited toazo dyes, quinopthalone dyes, triphenylmethane dyes, xanthene dyes,indigoid dyes, iron oxides, iron hydroxides, titanium dioxide, naturaldyes, and mixtures thereof. More specifically, suitable colorantsinclude, but are not limited to patent blue V, acid brilliant green BS,red 2G, azorubine, ponceau 4R, amaranth, D&C red 33, D+C red 22, D+C red26, D+C red 28, D+C yellow 10, FD+ C yellow 5, FD+C yellow 6, FD+ C red3, FD+ C red 40, FD+ C blue 1, FD+ C blue 2, FD+ C green 3, brilliantblack BN, carbon black, iron oxide black, iron oxide red, iron oxideyellow, titanium dioxide, riboflavin, carotenes, anthocyanins, turmeric,cochineal extract, clorophyllin, canthazanthin, caramel, betanin, andmixtures thereof.

In one embodiment, the dosage form is comprised of a) a core; b) anoptional first coating layer comprised of a subcoating thatsubstantially covers the core; and c) a second coating layer on thesurface of the first coating layer, the second coating layer comprisedof the coating composition of the present invention. As used herein,“substantially covers” shall mean at least about 95% of the surface areaof the core is covered by the subcoating. In a preferred embodiment thecore contains a pharmaceutically active ingredient.

In an alternate embodiment, a first active ingredient may be containedin the first coating layer, and the core may contain a second activeingredient and/or an additional amount of the first active ingredient.In yet another embodiment, the active ingredient may be contained in thefirst coating layer, and the core may be substantially free, i.e., lessthan about 1%, e.g. less than about 0.1%, of active ingredient.

The use of subcoatings is well known in the art and disclosed in, forexample, U.S. Pat. No. 3,185,626, which is incorporated by referenceherein. Any composition suitable for film-coating a tablet may be usedas a subcoating according to the present invention. Examples of suitablesubcoatings are disclosed in U.S. Pat. Nos. 4,683,256, 4,543,370,4,643,894, 4,828,841, 4,725,441, 4,802,924, 5,630,871, and 6,274,162,which are all incorporated by reference herein. Additional suitablesubcoatings include one or more of the following ingredients: celluloseethers such as hydroxypropylmethylcellulose, hydroxypropylcellulose, andhydroxyethylcellulose; polycarbohydrates such as xanthan gum, starch,and maltodextrin; plasticizers including for example, glycerin,polyethylene glycol, propylene glycol, dibutyl sebecate, triethylcitrate, vegetable oils such as castor oil, surfactants such aspolysorbate-80, sodium lauryl sulfate and dioctyl-sodium sulfosuccinate;polycarbohydrates, pigments, and opacifiers.

The first embodiment of the present invention is directed to a novelrotary die apparatus and a method of enrobing cores using same.Initially, it is noted that, while various types of stock film formingmaterials are suitable for use in the embodiments described herein,gelatin-based materials are preferred.

U.S. Pat. Nos. 5,146,730 and 5,459,983 provide a complete and detaileddescription of the rotary die apparatus and method of enrobing cores toproduce gelcaps suitable for use in the apparatus and method of thefirst embodiment. Accordingly, only those portions of the rotary dieenrobing apparatus and process that are new and/or modified inaccordance with the present invention will be described in full detailhereinafter.

Referring now to FIGS. 9-11, there are shown front (see FIG. 9), top(see FIG. 10) and side (see FIG. 11) representations of a film castingapparatus 30 used to produce a patterned film, more particularly astriped film 32, for enrobing cores 10 in accordance with the firstembodiment of the present invention. More particularly, the film castingapparatus 30 includes film receiving means, such as a conventionalcasting drum 34 (see FIGS. 9 and 11), for receiving the film 32 castthereon, as described in further detail hereinafter. The casting drum 34rotates at a controllable rate in the direction indicated by the arrow Bin FIG. 11. The casting drum 34 has an exterior surface 36, which may bepolished and which may be cooled by conventional cooling means, such ascirculating cooled water within the drum (not shown), for reasonsdiscussed hereinafter.

With reference now, in particular, to FIGS. 10 and 11, the film castingapparatus 30 further includes film depositing means, such as amulti-chamber slit extruder 38, for depositing the film 32 (see FIGS.9-11) onto the casting drum 34. The film 32 is made of any stock filmforming materials 40, 42 that are suitable for use in conjunction withthe multi-chamber slit extruder 38. It is noted that FIG. 10 shows thefilm casting apparatus 30 as viewed from the top; and, therefore, itshows the interior 44 of the multi-chamber slit extruder 38. FIG. 11shows the film casting apparatus 30 from the left side (i.e., looking inthe direction of arrow A in FIG. 9), with the slit extruder 38 inpartial cross section, such that the interior 44 thereof is partiallyvisible. As shown in these figures, the slit extruder 38 has, generally,a floor panel 46 and four exterior walls 48, 50, 52, 54 (see FIG. 10),which define the interior 44 of the slit extruder 38. The slit extruder38 also includes flow control means, such as a slidable gate 56 (seeFIG. 11), for a purpose to be described hereinafter. Three partitions58, 60, 62 divide the interior 44 of the slit extruder 38 into fourchambers 64, 66, 68, 70. In this regard, it is noted that the slitextruder 38 may include more or fewer partitions than are shown in thepresent embodiment resulting in more or fewer chambers, respectively,than are shown in the present embodiment. The film casting apparatus 30also includes supply means, such as feeder pipes 72, 74 (shown inpartial cross section in FIGS. 9-11 to reveal the stock film formingmaterials 40, 42 flowing therethrough) for supplying stock film formingmaterials 40, 42 to the chambers 64, 66, 68, 70 in a manner to bedescribed hereinafter.

As can be seen best in FIG. 11, one of the exterior walls 48 of the slitextruder 38 may have an inner surface 76 that is sloped toward the floorpanel 46 and terminates proximate thereto, thus forming an open slit 78between the bottom-most portion of the wall 48 and the floor panel 46.The open slit 78 communicates with each of the chambers 64, 66, 68, 70of the slit extruder 38 to allow passage therethrough of the stock filmforming materials 40, 42. The slit extruder 38 is heated by conventionalheating means, such as electric coils, or coils with hot watercirculating therein (not shown), for the purpose of heating the stockfilm forming materials 40, 42 to (or maintaining the stock film formingmaterials 40, 42 at) a flowable liquid state, such that the stock filmforming materials 40, 42 will flow through the slit 78 and out of thechambers 64, 66, 68, 70 in a manner to be described hereinafter. Thewidth of the slit 78, and, hence, the thickness of the resulting film32, is adjusted by moving the slidable gate 56 in the directionsindicated by arrow C in FIG. 11.

The slit extruder 38 may also include a top cover 80 (see FIGS. 9 and11) to facilitate pressurizing the interior 44 of the slit extruder 38by conventional pressurizing means (not shown), which will encourage thestock film forming materials 40, 42 to flow out of the chambers 64, 66,68, 70 in a manner to be described hereinafter. As a further optionalfeature, the slit extruder 38 may include an interior roller 82 (seeFIG. 11), which is adapted to rotate in the direction indicated by thearrow D so as to encourage the stock film forming materials 40, 42 toflow out of the chambers 64, 66, 68, 70 in a manner to be describedhereinafter.

As shown in FIGS. 9-11, when the chambers 64, 66, 68, 70 of the slitextruder 38 contain differently colored stock film forming materials 40,42 in alternating chambers 64, 66, 68, 70 (e.g., “red” stock material 40in the chambers 64, 68 and “yellow” stock material 42 in the chambers66, 70), the resulting film 32 will have differently colored stripes(i.e., red stripes 84, 88 and yellow stripes 86, 90). In addition, wherethe slit extruder 38 includes more or fewer chambers than are shown inFIGS. 9-11, the resulting striped film 32 will have more or fewerstripes, respectively, than the film 32 shown in the present embodiment.

It is noted that, of course, the stock film forming materials 40, 42need not be of different colors, but rather, they can be visuallydistinct from one another by having, for example, different colors,hues, glosses, reflective qualities, brightness, depth, shades, chroma,opacity, etc. Red and yellow stock film forming materials 40, 42,respectively, are discussed herein merely by way of example and, itshould be understood that stock film forming materials that are visuallydistinct from one another in other ways, as mentioned above, are alsosuitable for use with the apparatus and method of the present invention.Furthermore, stock film forming materials 40, 42 of more than twodifferent colors (for example, four stock materials of four differentcolors), or other visual distinctions (such as, for example, a firstflat stock material, a second glossy stock material and a third stockmaterial having reflective qualities), may also be used. It is furthernoted that the stock film forming materials 40, 42 may be of differentis chemical compositions (i.e., they need not both be made of polymer orstarch-based materials, or even of the same polymer or starch-basedformulation) and still be suitable for use with the apparatus andmethods of the present invention as long as the stock film-formingmaterials are sufficiently compatible with one another such that theywill form a continuous patterned film by the methods describedhereinafter.

With reference now to FIGS. 12 and 13, to ensure that the colortransitions 92 a, 92 b, 92 c between stripes 84, 86, 88, 90 of differentcolors (or visual distinction) in the film 32 are straight andconsistent (see, e.g., FIG. 9), the slit extruder 38 includes a stripecontrol means, such as a tapered blade edge 94, 96, 98 on each partition58, 60, 62, respectively, to control the flow of the stock film formingmaterials 40, 42 as they exit the chambers 64, 66, 68, 70. FIG. 12 showsa single isolated partition 58, removed from the slit extruder 38 andhaving a tapered blade edge 94, as well as a hole 100 that is sized andshaped to rotatably receive the interior roller 82 therethrough. Asshown in FIG. 13, when the partitions 58, 62, 62 and the interior roller82 are properly installed within the slit extruder 38, the tapered edge94, 96, 98 of each partition 58, 60, 62, respectively, rests upon thefloor panel 46 and extends across the slit 78.

The operation of the film casting apparatus 38, by which striped film 32is produced, will now be described in detail using FIGS. 9-13 asreferences. Initially, one feeder pipe 72 supplies the stock filmforming material 40 of one color (or visual distinction), such as red,to two alternate chambers 64, 68 of the slit extruder 38, while theother feeder pipe 74 supplies stock film forming material 42 of anothercolor (or visual distinction), such as yellow, to the remaining twochambers 66, 70. The stock film forming materials 40, 42 may be providedto the extruder 38 in the form of liquid, a solid, or a semi-solid, andmay be at any desired temperature. A conventional heating means (notshown) of the slit extruder 38 may be activated, thereby heating thestock film forming materials 40, 42 within the chambers 64, 66, 68, 70to a predetermined temperature (or maintaining the stock film formingmaterials 40, 42 at such a temperature), at which the stock film formingmaterials 40, 42 become liquid and flowable or may be maintained in aliquid and flowable state. Depending upon the type and composition ofthe stock film forming materials 40, 42, it may be exposed to atemperature between about 40 degrees Celsius and about 250 degreesCelsius. For example, where the stock film forming materials 40, 42 aregelatin based or hydroxypropyl methylcellulose based, then theappropriate temperature range for heating within the slit extruder 38would be between about 40 degrees Celsius and about 190 degrees Celsius.Alternatively, where the stock film forming materials 40, 42 are starchbased, then the appropriate temperature range for heating within theslit extruder 38 would be between about 80 degrees Celsius and about 240degrees Celsius.

According to known, conventional processes, the rotation of the castingdrum 34 is commenced and the exterior surface 36 of the casting drum 34is cooled by conventional cooling means (not shown) to a predeterminedtemperature that will, at least partially, solidify the stock filmforming materials 40, 42 upon their physical contact with the surface 36of the drum 34 to form the striped film 32, as described in furtherdetail hereinafter. One skilled in the art would readily appreciate,without undue experimentation, the proper predetermined temperature forthe exterior surface 36 of the drum 34 will depend upon several factorssuch as, for example, the type and composition of the stock film formingmaterials 40, 42 and the desired thickness of the resulting film 32. Forexample, where the stock film forming materials 40, 42 are gelatin basedor hydroxypropyl methylcellulose based, and the desired film thicknessis about 0.1 millimeters to about 2.0 millimeters, then the appropriatetemperature range for cooling the exterior surface 36 of the castingdrum 34 would be between about 2 degrees Celsius and about 50 degreesCelsius. Alternatively, where the stock film forming materials 40, 42are thermoplastic starch based, and the desired film thickness is about0.1 millimeters and about 2.0 millimeters, then the appropriatetemperature range for cooling the surface 36 of the drum 34 would bebetween about 20 degrees Celsius and about 100 degrees Celsius.

After the stock film forming materials 40, 42 are heated to, ormaintained at, the appropriate predetermined temperature and theexterior surface 36 of the casting drum 34 is cooled to the appropriatepredetermined temperature, the slidable gate 56 of the slit extruder 38is moved to a position which opens the slit 78 to the thickness that isdesired for the film 32. The stock film forming materials 40, 42 thenflow out of their respective chambers 64, 66, 68, 70, along the taperedblade edges 94, 96, 98, through the slit 78, and onto the casting drum34, in a controlled manner, in the direction of the arrow E in FIG. 9.The aforesaid apparatus' and procedure result in the production of acontinuous ribbon of striped film 32, having alternating red stripes 84,88 and yellow stripes 86, 90, with straight and consistent colortransitions 92 a, 92 b, 92 c therebetween. The film 32 is continuouslyremoved from the casting drum 34 by a scraper or similar device (notshown).

With reference now to FIGS. 14-16, a summary of the enrobing apparatus102 (see FIG. 14) in accordance with the first embodiment of the presentinvention will now be provided. Reference is also made to U.S. Pat. Nos.5,146,730 and 5,459,983, which both provide a detailed description ofthe enrobing apparatus 102.

With reference in particular to FIG. 14, it is noted that the enrobingapparatus 102 has a central plane of symmetry 104 about which thevarious equipment that comprises the enrobing apparatus 102 arearranged. As depicted schematically in FIG. 14, it can be seen that theequipment of the enrobing apparatus 102 on one side of the central planeof symmetry 104 is basically the same type as the equipment on the otherside of the central plane of symmetry 104 and is arranged, generally, ina mirror image thereof. More particularly, a film casting apparatus 30,30′ is positioned at each of the opposite ends of the enrobing apparatus102 and each film casting apparatus 30, 30′ produces a striped film 32,32′, respectively. Each film 32, 32′ is moved in a continuous manner, bya series of rollers 106, 108, 110, and 106′, 108′, 110′, respectively,toward a pair of coacting rotary dies 112, 112′, which are positionedsymmetrically on either side of the central plane of symmetry 104. Therotary dies 112, 112′ rotate on their axes of rotation AR, AR′,respectively, in the directions of arrows F, F′, respectively, therebyforming a nip therebetween. The nip between the rotary dies 112, 112′lies in the aforesaid central plane of symmetry 104 and the stripedfilms 32, 32′ are passed therethrough.

Each film 32, 32′ includes a top or contact surface 32 a, 32 a′ and areverse surface 32 b, 32 b′, respectively (see FIG. 14). Shortly afterthe striped films 32, 32′ are cast and removed from the cooled castingdrums 34, 34′, as described earlier hereinabove, the reverse surface 32b, 32 b′ of each film 32, 32′ may be lubricated in a lubricant bath 114,114′ to facilitate their movement over the rollers 106, 108, 110, 106′,108′, 110′. Suitable lubricants include any fats or oils, which arewell-known in the art for such use. Just prior to the passage of thefilms 32, 32′ into the nip between the rotary dies 112, 112′, thecontact surface 32 a, 32 a′ of each of the films 32, 32′ may be heatedby conventional heating means 116, 116′ to facilitate their bonding toone another as they pass between the rotary dies 112, 112′.

The enrobing apparatus 102 also includes a core dispensing means 118,which holds a supply of cores 10 and dispenses them to the nip betweenthe rotary dies 112, 112′ in a timed manner. Although this embodiment isillustrated as enrobing cores, it is within the scope of the presentinvention to alternatively enrobe any substrate with a desired filmcoating, including but not limited to a hard or soft capsules, gels,lozenges, nougats, fondants, etc., or other confectionery. The coredispensing means 118 is aligned with the central plane of symmetry 104and the nip formed between the rotary dies 112, 112′. The coredispensing means 118 orients and dispenses each core 10 such that thecore 10 simultaneously contacts the contact surfaces 32 a, 32 a′ of theconverging striped films 32, 32′ as the core 10 enters the nip betweenthe dies 112, 112′, with its transverse plane of symmetry 16 lying inthe central plane of symmetry 104 of the enrobing apparatus 102, and thecolor transitions 92 a, 92 a′ of the films 32, 32′, respectively, lyingin the conjugate plane of symmetry 18 of the core 10. The films 32, 32′are then stretched around the opposite sides of each core 10symmetrically, relative to the central plane of symmetry 104 of theenrobing apparatus 102.

FIG. 15 shows the proper positioning of the cores 10 in between thestriped films 32, 32′ as they enter the nip between the dies 112, 112′and relative to the color transitions 92 a, 92 b, 92 c, 92 a′, 92 b′, 92c′ of each film 32, 32′. In FIG. 15, the first film 32 is partially cutaway to show the cores 10 placed on the second film 32′. The cores 10that are shown in phantom in FIG. 15 are sandwiched in between the films32, 32′, thereby showing how the color transitions 92 a, 92 b, 92 c ofthe first film 32 align with the color transitions 92 a′, 92 b′, 92 c′of the second film 32′, respectively, and how all of the colortransitions 92 a, 92 b, 92 c, 92 a′, 92 b′, 92 c′ are aligned with theconjugate plane of symmetry 16 (not shown on the phantom cores 10) of acorresponding core 10.

Furthermore, the enrobing apparatus 102 preferably includes registeringmeans 120 (shown only schematically in FIG. 14) for ensuring that thecolored stripes (not shown) of the films 32, 32′ are properly alignedwith one another prior to passage between the rotary dies 112, 112′. Theregistering means 120 also ensures that the positions of the dispensedcores 10 are appropriate relative to the color transitions 92 a, 92 b,92 c, 92 a′, 92 b′, 92 c′ of the films 32, 32′, respectively, such thatthe color transition between the colors on the resulting gelcap products122 are properly matched with one another and the conjugate plane ofsymmetry 18 of each core 10. More particularly, the registering means120 (shown schematically only in FIG. 14) may include any one of manyany other conventional, known types of optical sensory and controldevices (commercially available from Contrex, Inc. of Maple Grove, Minn.and Ormec Systems Corp. of Rochester, N.Y.), as well as any otherconventional, known mechanical adjusting means for adjusting theposition of one or both of the films 32, 32′, as necessary.

With reference now to FIG. 16, an enlarged schematic perspective view ofthe drum-like rotary dies 112, 112′ is provided. As shown, the rotarydies 112, 112′ are substantially identical to one another, each havingan exterior circumferential surface 124, 124′ with a series of recesses126, 126′ thereon. The recesses 126, 126′ are arranged in rows, whichextend circumferentially around each rotary die 112, 112′.

Furthermore, each recess 126, 126′ has a raised rim 128, 128′ about itsperiphery for a purpose to be described hereinafter. It is noted that,as shown in FIG. 16, each recess 126, 126′ is shaped to conform to theshape of the cores 10 being enrobed. More particularly, for purposes ofthe present illustration wherein oblong cores 10 are being enrobed, eachrecess 126, 126′ has a length 130, 130′ and a width 132, 132′ and eachis arranged such that its length 130, 130′ is aligned parallel to theaxis of rotation AR, AR′ of its respective rotary die 112, 112′. Inaddition, it is contemplated that each die 112, 112′ may have adifferent number of rows of recesses 126, 126′ than are shown in thepresent embodiment, as long as there are the same number of rows on eachdie 112, 112′ so that each recess 126 on one die 112 can cooperate witha corresponding recess 126′ on the other die 112′, as described infurther detail hereinafter. In addition, the number of rows of recesses126, 126′ should correspond to the number of color transitions 92 a, 92b, 92 c, 92 a′, 92 b′, 92 c′ between the stripes 84, 86, 88, 90, 84′,86′, 88′, 90′ on the striped films 32, 32′, respectively, that passbetween the dies 112, 112′, for reasons which will be apparent basedupon the operation of the enrobing apparatus 102 described hereinafter.The dies 112, 112′ should be at or below room temperature and may bebrought to, or maintained at, such temperature by any suitableconventional, known temperature control means (not shown). In addition,if desired, the exterior circumferential surfaces 124, 124′, includingthe recesses 126, 126′, of each die 112, 112′, respectively, may betreated so as to reduce the tendency of the films 32, 32′ to stickthereto, such as, for example, applying a suitable conventionallubricant thereto, or coating the surfaces 124, 124′ with TEFLON® oranodizing the surfaces 124, 124′.

As can be seen in FIG. 16, the orientation of the striped films 32, 32′as they pass between the rotary dies 112, 112′ is such that the redstripes 84, 88 of one film 32 are matched with the red stripes 84′, 88′of the other film 32′ and the yellow stripes 86, 90, 86′, 90′ of eachfilm 32, 32′, respectively, are similarly matched with one another. Theregistering means 120 of the enrobing apparatus 102 may be used tofacilitate the orientation of the films 32, 32′ such that the matchingand alignment of the color transitions 92 a, 92 b, 92 c, 92 a′, 92 b′,92 c′ of each film 32, 32′, respectively, are improved.

As the dies 112, 112′ rotate, each recess 126 of one rotary die 112cooperates with a corresponding recess 126′ on the other rotary die 112′at the nip between the dies 112, 112′ to form a cavity therebetween. Therecesses 126, 126′ are sized and shaped such that the cavities formedtherebetween are slightly larger than the enrobed core 10, therebypreventing unnecessary contact between the films 32, 32′ and theinterior surfaces of the recesses 126, 126′. As the rotary dies 112,112′ rotate, the cores 10 are dispensed to the nip between the dies 112,112′ such that they are oriented with their lengths aligned parallel tothe axes of rotation AR, AR′ of the dies 112, 112′ and each core 10 isthereby properly aligned to be received between a pair of coactingrecesses 126, 126′. The rotary dies 112, 112′ continue to rotate and thefilms 32, 32′ are sealed to each other by the raised rims 128, 128′ ofthe coacting recesses 126, 126′, around the core 10 thereby forming afilm seam 134, which lies in the transverse plane of symmetry 16 of thecore 10. The raised rims 128, 128′ also cut through the bonded films 32,32′, at the film seam 134 around each enrobed core 10, thereby releasingthe enrobed core products, or gelcaps 122, from the bonded films 32,32′.

With reference to the film seam 134 of the gelcaps 122, it is noted thatin addition to the configuration described above wherein the films 32,32′ are sealed together and cut by the raised rims 128, 128′ of thecoacting recesses 126, 126′ thereby resulting in abutting film edgesthat form the film seam 134, it is also possible to have a film seam 134wherein the cut edge of one film 32 slightly overlaps the cut edge ofthe other film 32′ by an amount approximately equal to the thickness ofthe films 32, 32′.

Alternatively, the film seam 134 could be formed such that the cut edgesof the films 32, 32′ are aligned with one another about the core 10, butare spaced apart slightly by a distance that is approximately equal tothe thickness of the films 32, 32′. Regardless of which of the foregoingtypes of film seams 134 (i.e., abutting, overlapping or spaced apart)that is formed on the gelcap product 122, the film seam 134 liessubstantially in the transverse plane of symmetry 16 of the core 10. Itshould be understood that the foregoing discussion of the possible typesof film seams also applies to all embodiments of the present inventiondiscussed hereinafter.

As shown in FIGS. 14 and 16, the film coatings of the resulting gelcaps122 conform tightly and snugly to the cores 10, thereby resulting intamper-proof gelcap products 122. In addition, the resulting gelcapproduct 122 is bi-colored, the film seam 134 lying in the transverseplane of symmetry 16 of the core 10 and the color transition 136 lyingin the conjugate plane of symmetry 18 of the core 10. As a result, thecolor transition 136 of each of the gelcaps 122 may be flush andseamless (i.e., without any raised portion which generally characterizesthe film seam 134). In addition, the foregoing process may result ingelcap products 122 having a film coating of uniform color quality andthickness over their entire surface.

If aesthetically desired, the films 32, 32′ may be aligned such that theresulting gelcaps 122 have a film seam 134 wherein a stripe of one color(for example, a red stripe 84) (or visual distinction) of one film 32abuts or overlaps a stripe of another color (for example, a yellowstripe 90′) (or visual distinction) of the other film 32′ to form agelcap 122 having a “checkerboard pattern”, i.e., having four quadrantsof alternating red and yellow colors (or other visual distinctions) (notshown).

After being cut and released from the bonded films 32, 32′ in a mannerdisclosed in U.S. Pat. Nos. 5,146,730 and 5,459,983, the gelcaps 122 maybe collected in collecting chutes and/or conveyors (not shown) andtransported to further processing equipment (not shown) for furtherprocess steps in which the lubricants may be removed, the gelcaps 122may be dried and/or, if desired, additional coatings or identifyingmarkings may be added.

As illustrated in FIGS. 17-21, the second embodiment of the presentinvention is directed to an alternative method for producing stripedfilm having transversely oriented stripes, using rotary die apparatusand process that are nearly identical to those described above.

With reference particularly, to FIGS. 17-19, a simplified, schematicrepresentation is provided of an alternative film casting apparatus 136,which produces the aforesaid transversely striped film 138 for enrobingcores 10 in accordance with the second embodiment of the presentinvention. More particularly, FIG. 17 shows an elevated side view of thealternative film casting apparatus 136, while FIG. 18 shows a top planview thereof. FIG. 19 shows an elevated front view of the alternativefilm casting apparatus 136, as viewed from the position of line G—G inFIG. 18 and looking in the direction of the arrows.

Referring now to FIG. 17, the alternative film casting apparatus 136includes film receiving means, such as a conventional metal casting belt140 that is mounted onto two rotating drums 142, 144, for receiving thefilm 138 being cast thereon, as described in further detail hereinafter.The rotating drums 142, 144 rotate at a controllable rate in thedirections indicated by the arrows H and I respectively, in FIG. 17,thereby causing the casting belt 140 to move in the directions indicatedby the arrows J and K. While the casting belt 140 can be made ofsuitable materials other than metal that will removably receive the film138 thereon, such as carbon steel or stainless steel available from BeltTechnology of Agawam, Mass., metal is the preferred material. Thesurface of the casting belt 140 may be polished to reduce the tendencyof the film 138 to stick thereon. In addition, a warming plate 148 maybe positioned adjacent to the casting belt 140 to warm the casting belt140 prior to casting film thereon, for a purpose discussed hereinafter.A cooling plate 150 is positioned adjacent to the casting belt 140 tocool the casting belt 140 after film is cast thereon, for a purpose thatis also discussed hereinafter.

As shown in each of FIGS. 17-19, the alternative film casting apparatus136 further includes film depositing means, such as a reciprocatingmulti-chamber slit extruder 146, for depositing the film 138, in asemi-continuous manner, as described hereinafter, onto the casting belt138. Such extruders are conventional and well known to persons havingordinary skill in the art and are available commercially from varioussources, including, but not limited to, Wenger Manufacturing of KansasCity, Mo. and Coperion Corporation of Ramsey, N.J. The configuration andoperation of the slit extruder 146 are nearly identical to those of theslit extruder 38 of the first embodiment of the present invention. Moreparticularly, as with the slit extruder 38 previously discussedhereinabove, the reciprocating slit extruder 146 includes interiorpartitions 152, 154, 156 that form interior chambers 158, 160, 162, 164for holding visually distinct stock film forming material 166, 168therein. As shown in FIG. 18, red stock film forming material 166 isheld in chambers 158, 162 and yellow stock film forming material 168 isheld in chambers 160, 164. A slit 170 is also provided, through whichthe stock film forming materials 166, 168 flow out of the chambers 158,160, 162, 164 and onto the casting belt 140, thereby creating a stripedfilm 138 as described hereinafter.

The reciprocating slit extruder 146 also includes supply means, such asfeeder pipes 182, 184 for supplying the stock film forming materials166, 168 to each of the chambers 158, 160, 162, 164 and flow controlmeans, such as a slidable gate 180 (see FIG. 19), for controlling theflow of the stock film forming materials 166, 168 from the chambers 158,160, 162, 164. The width of the slit 170, and, thereby, the thickness ofthe resulting film 138, is adjusted by moving the slidable gate 180 inthe directions indicated by arrow L in FIG. 19. In addition, as with theslit extruder 38 previously discussed hereinabove, the reciprocatingslit extruder 146 of the second embodiment may be heated by conventionalheating means, such as electric coils, or coils with hot watercirculating therein (not shown), for the purpose of heating the stockfilm forming materials 166, 168 to a flowable liquid state, (ormaintaining the stock film forming materials 166, 168 at such state),such that the stock film forming materials 166, 168 will flow easily outof each chamber 158, 160, 162, 164 and through the slit 170.

Each of the interior partitions 152, 154, 156 of the reciprocating slitextruder 146 has stripe control means, such as a tapered blade edge (notshown, but similar to the tapered blade edges 94, 96, 98 of thepartitions 58, 60, 62 shown in FIG. 13 in connection with the firstembodiment), to control the flow of the stock film forming materials166, 168 exiting the chambers 158, 160, 162, 164. As with the slitextruder 38 of the first embodiment, the tapered blade edges (not shown)of the interior partitions 152, 154, 156 of the reciprocating slitextruder 146 ensure the formation of straight and consistent colortransitions 186, 188, 190 between the stripes of the film 138 as thefilm 138 is cast onto the casting belt 140.

Also similar to the slit extruder 38 of the first embodiment, thereciprocating slit extruder 146 may include a top cover 192 tofacilitate pressurizing its interior, by conventional pressurizing means(not shown), thereby promoting the flow of the stock film formingmaterials 166, 168 out of the chambers 158, 160, 162, 164.Alternatively, the reciprocating slit extruder 146 may include arotatable interior roller (not shown) positioned therein (see FIG. 11),which would also promote the flow of the stock film forming materials166, 168 out of the chambers 158, 160, 162, 164.

With reference, in particular, to FIGS. 18 and 19, one notabledifference between the slit extruder 38 of the first embodiment and thereciprocating slit extruder is 146 of the second embodiment is that thereciprocating slit extruder 146 is connected to a conventional motor(not shown), in a manner that is known and familiar to those havingordinary skill in the art, such that R moves reciprocatingly in thedirections indicated by arrow M in FIG. 18. For example, suitablereciprocating mechanisms are discussed in the following two books:Sclater and Chironis, Mechanisms and Mechanical Devices Sourcebook, Ch.4 Reciprocating Mechanisms, McGraw-Hill Professional, June 2001 andJones, et al., Ingenious Mechanism, Vol. 1 Driving Mechanisms forReciprocating Parts, Industrial Press, November 1990, both of which areherein incorporated by reference.

More particularly, the reciprocating slit extruder 146 is movablebetween a first position 194 (shown in phantom in FIG. 19) and a secondposition 196 (also shown in phantom in FIG. 19), for a purpose describedin detail hereinafter. Such movement of the reciprocating slit extruder146 occurs at a constant speed and at timed intervals that arecontrolled and regulated by a combination of conventional motors (notshown) and registering means (not shown), such as those mentioned abovein connection with the first embodiment of the present invention.

Other notable differences between the slit extruder 38 of the firstembodiment and the reciprocating slit extruder 146 relate to theoperation of the reciprocating slit extruder 146 and will becomeapparent from the following description. The operation of thealternative film casting apparatus 136, by which the transverselystriped film 138 is produced, will now be described in detail, usingFIGS. 17-19 as references.

Initially, the feeder pipes 182, 184 supply stock film forming materials166, 168 of two colors, such as red and yellow, respectively, toalternate chambers 158, 160, 162, 164, respectively, of thereciprocating slit extruder 146. The conventional heating means (notshown) of the reciprocating slit extruder 146 is activated, therebyheating or maintaining the stock film forming materials 166, 168 withinthe chambers 158, 160, 162, 164 to a predetermined temperature, at whichthe stock film forming materials 166, 168 becomes or is maintained asliquid and flowable. The warming plate 148 may also be warmed to apredetermined temperature that is sufficient to maintain the aforesaidliquid and flowable characteristics of the stock material 166, 168 for abrief amount of time. The preferred temperatures for the stock material166, 168 and the warming plate 148 are determined, based upon the typeof stock material 166, 168 being used, in the same manner as describedhereinabove in connection with the first embodiment of the presentinvention.

The cooling plate 150 is cooled by conventional cooling means (notshown) to a predetermined temperature that will, at least partially,solidify the stock material 166, 168 upon physical contact with thesurface of the casting belt 140 to form the transversely striped film138, as described in further detail hereinafter. One skilled in the artwould readily appreciate, without undue experimentation, that the properpredetermined cooled temperature for the cooling plate 150 will dependupon a number of factors, including the type and composition of thestock film forming materials 166, 168 and the desired thickness of thetransversely striped film 138, and may be determined in the same manneras described earlier hereinabove in connection with preferredtemperature for the casting drum 34 of the first embodiment of thepresent invention.

After the stock film forming materials 166, 168, the warming plate 148and the cooling plate 150 have attained their desired temperatures, aportion 198 of the casting belt 140 is warmed by the warming plate 148and is then advanced by the rotating drums 142, 144 to a positionunderneath the reciprocating slit extruder 146.

The slidable gate 180 is then moved to a position which opens the slit170 to the thickness that is desired for the striped film 138. While therotating drums 142, 144 and the casting belt 140 remain stationary, thestock film forming materials 166, 168 flow out of the chambers 158, 160,162, 164, along the tapered blade edges (not shown), through the slit170 and onto the warmed portion 198 of the casting belt 140, whichbriefly maintains the stock material 166, 168 in a substantially liquid,flowable state.

Simultaneously with the flow of the stock film forming materials 166,168 onto the casting belt 140, the reciprocating slit extruder 146 ismoved from its first position 194, at a constant predetermined speed, inthe direction indicated by the arrow N in FIG. 19, to its secondposition 196, where it is temporarily halted. As soon as thereciprocating slit extruder 146 reaches its second position 196, theslidable gate 180 is moved to a closed position, thereby blocking theslit 170 and temporarily halting the flow of stock film formingmaterials 166, 168, which results in the formation of a film segment200. As seen in FIG. 18, the film segment 200 has alternating,transversely oriented red stripes 172, 176 and yellow stripes 174, 178with straight and consistent color transitions 186, 188, 190therebetween. The film segment 200 also has a first edge 202, a secondedge 204 and a width 206, which equals the sum of the widths of thestripes 172, 174, 176, 178.

Next, the casting belt 140 is moved by the rotating drums 142, 144 inthe direction shown by arrows J and K in FIG. 17, such that the filmsegment 200 is moved in the direction of the arrow J and a newly warmedportion of the casting belt 140 is positioned beneath the reciprocatingslit extruder 140. More particularly, the casting belt 140 is moveduntil the first and second edges 202, 204 of the film segment 200 areeach advanced by a distance that is equal to the width 206 of the filmsegment 200, in order to make room for the casting of a second filmsegment that will be contiguous with the first film segment 200. It isnoted that the cooling plate 150 is preferably positioned adjacent andbeneath the casting belt 140 at the location to which the first filmsegment 200 is moved. Thus, the first film segment 200 is cooled whilethe second film segment is cast onto the casting belt 140. It will beappreciated by those having ordinary skill in the art, that themovements of the rotating drums 142, 144 and the casting belt 140described above can be readily maneuvered and controlled by motors (notshown) and registration devices (not shown) that are well known andconventional, as discussed hereinabove.

When it is desired to cast a subsequent film segment, with thereciprocating slit extruder 146 now in its second position 196 and thecasting belt 140 held stationary, the slidable gate 180 is again movedto a position which opens the slit 170 by an amount that is equal to thethickness desired for the striped film 138. As the stock film formingmaterials 166, 168 flow out of the chambers 158, 160, 162, 164 and ontothe casting belt 140, the reciprocating slit extruder 146 is moved fromits second position 196, at a constant predetermined speed, back to itsfirst position 194, where it is again temporarily halted. As the stockfilm forming materials 166, 168 are being cast is onto the casting belt140, the first edge of the new film segment will meet and bond with thesecond edge 204 of the first film segment 200. After the reciprocatingslit extruder 146 returns to its first position 194, the slidable gate180 is again moved to its closed position, thereby blocking the slit 170and temporarily halting the flow of stock film forming materials 166,168, which results in the creation of a new film segment that is bondedto the first film segment 200.

The foregoing process steps are repeated continuously, resulting in afilm casting process that is semi-continuous and which produces acontinuous ribbon of transversely striped film 138. The transverselystriped film 138 is continuously removed from the casting belt 140 by ascraper or similar, known device (not shown) and advanced in thedirection of arrow J in FIG. 17. The transversely striped film 138 isthen fed into the rotary die enrobing apparatus 102 for enrobing cores10 as described above in connection with the first embodiment of thepresent invention. It is noted that, as shown in FIG. 20, except for theorientation of the recesses 210, 210′ on the rotary dies 208, 208′ (seeFIG. 20) and the orientation of the cores 10 that are dispensed to nipbetween the rotary dies 208, 208′ (see FIG. 20) by the core dispensingmeans 118, the enrobing apparatus 102 and its method of operation remainsubstantially unchanged.

More particularly, as can be seen in FIG. 20, because the alternativefilm casting apparatus 136 produces film 138 having stripes 172, 174,176, 178 that are transversely oriented, the rotary dies 208, 208′ ofthe second embodiment must have recesses 210, 210′ which are orientedsuch that their lengths 212, 212′ are aligned perpendicularly to theaxes of rotation AR, AR′ of their respective rotary dies 208, 208′. Inaddition, in accordance with the second embodiment, the core dispensingmeans (not shown) must orient and dispense each core 10 to the nipbetween the dies 208, 208′ end-first, i.e., such that one of the ends12, 14 of each caplet 10 simultaneously contacts the converging films138, 138′ as the core 10 enters the nip. In such an orientation of thecores 10, the color transitions 186, 188, 190, 186′, 188′, 190′ of thefilms 138, 138′, respectively, lie in the conjugate planes of symmetry18 of their corresponding cores 10 as the cores 10 enter the nip and areenrobed between the rotary dies 208, 208′. In this regard, FIG. 21(which is similar to FIG. 15) provides a visual example of the properpositioning of the cores 10, at the nip between the dies 208, 208′, inbetween the transversely striped films 138, 138′ and relative to thecolor transitions 186, 188, 190, 186′, 188′, 190′ thereof, respectively.

As shown in FIG. 20, the resulting gelcap products 214 are bi-colored,having a film seam 216 that lies in the transverse plane of symmetry 16of the core 10, and having a color transition 218 that lies in theconjugate plane of symmetry 18 of the core 10. The color transition 218of the gelcap 214 may be flush and seamless, i.e., without any raisedportion, and the film coating may be of uniform thickness and colorquality over the entire surface of the gelcap 214. If aestheticallydesired, the films 138, 138′ may be aligned such that the resultinggelcaps 214 have a film seam 216 wherein a stripe of one color or visualdistinction (for example, a red stripe 172) of one film 138 abuts oroverlaps a stripe of another color or visual distinction (for example, ayellow stripe 178′) of the other film 138′ to form a gelcap 214 having a“checkerboard pattern” (not shown), i.e., having four quadrants ofalternating red and yellow colors or other visual distinctions.

After being cut and released from the bonded films 138, 138′ in the samemanner as disclosed in U.S. Pat. Nos. 5,146,730 and 5,459,983, thegelcaps 214 may be collected in collecting chutes and/or conveyors (notshown) and transported to further processing equipment (not shown) forfurther process steps in which the lubricants may be removed, thegelcaps 214 may be dried and/or, if desired, additional coatings oridentifying markings may be added.

As illustrated in FIGS. 22-30, the third embodiment of the presentinvention is directed to an alternative enrobing apparatus (see,especially, FIGS. 22 and 26), which includes the alternative filmcasting apparatus 136 of the second embodiment and the transverselystriped film 138 produced thereby. In a process described in detailhereinafter, the transversely striped film 138 is fed, along with thecores 10, into the alternative enrobing apparatus to produce bi-coloredgelcap products, each having a film seam that only partiallycircumscribes the gelcap and which lies in a reference plane that isdifferent from the reference plane in which the color transition of thegelcap lies.

With reference initially to FIGS. 22, 23 and 26-30, the alternativeenrobing apparatus in accordance with the third embodiment of thepresent invention includes a conveyor system 220 (see FIG. 22) thatcomprises a series of horizontally-oriented rollers 222 and pairs ofrollers, 224, 226, 228 (see FIGS. 26-30), for supporting and conveyingthe transversely striped film 138. The conveyor system 220 will bedescribed in greater detail hereinafter in connection with FIG. 26.

It will be recalled that the film 138 has alternatetransversely-oriented red stripes 172, 176 and yellow stripes 174, 178with color transitions 186, 188, 190 therebetween (see, e.g., FIGS. 18and 20), although, as set forth above, any stock film forming materialshaving other colors or other visual distinctions or appearances aresuitable. A core dispensing means 230 is positioned above the conveyorsystem 220 and the film 138 for the purpose of dispensing the cores 10onto the film 138 in the required orientation with respect to the colortransitions 186, 188, 190 (see, e.g., FIGS. 25A-25C).

The core dispensing means 230 includes a core hopper 232 for holding thecores 10 to be enrobed prior to their entry into a series of slatfeeders 234, 236, which are of a well-known type and are commerciallyavailable from DT Lasko Merrill of Leominster, Mass., as well as fromAylward Enterprises, Inc. of New Bern, N.C. and Integrated PackagingSystems, Inc. of Parsippany, N.J. The slat feeders 234, 236 typicallyinclude a series of internal brushes and wheels (not shown) that orientthe cores as required for proper positioning onto the film 138.

The core dispensing means 230 further includes a core positioning slat238 and a core plunger 240, which is positioned above the positioningslat 238 and is moved reciprocatingly in the directions shown by thearrow P in FIG. 22 by a conventional motor (not shown), such as ahydraulic motor (not shown), in a well-known manner. A registering means242 (shown schematically only in FIG. 22) is also included to assist inthe proper positioning of the caplets 10 onto the film 138, as describedhereinafter. The registering means 242 includes any one of manyconventional, known types of optical sensory and control devices (notshown, but discussed above in connection with the first embodiment). Theregistering means 242 also includes conventional, known mechanicaladjusting means (not shown), such as a stepper motor (not shown), foradjusting the speed and position of the advancing film 138 on theconveyor system 220, as necessary. Such stepper motors are commerciallyavailable from various sources including, but not limited to, Bayside ofPort Washington, N.Y., and are well known to persons having ordinaryskill in the art.

The positioning slat 238, more particularly, has a pair of externalwalls 244, 246, each with a core support rail 248, 250, respectively,one of which is shown in phantom in FIG. 22 and the other of which ispartially visible in FIG. 23. The walls 244, 246 are sized and shaped soas to receive therebetween caplets 10 having their transverse planes ofsymmetry 16 aligned with the length of the walls 244, 246, as can bestbe seen in FIGS. 25A-25C. The support rails 248, 250 are each attachedto the inner surfaces 252, 254, respectively, of the walls 244, 246, andare sized and shaped such that each core 10 within the positioning slat238 is slideably supported simultaneously by each support rail 248, 250.Moreover, the walls 244, 246 are spaced apart from one another asufficient distance such that the cores 10 are in frictional, butmovable, contact with the inner surfaces 252, 254 of the walls 244, 246.Thus, when the cores 10 are no longer supported by the support rails248, 250, as described hereinafter, they are temporarily held suspendedabove the conveyor system 220 and the film 138.

In FIGS. 23 and 24A, it can be seen that the inner corners 256, 258 ofthe support rails 248, 250 may be rounded to prevent gouging or otherphysical damage to the cores 10 as they slide therealong. It is notedthat, depending upon the configuration of the cores 10, the shape of theinner corners 256, 258 of the support rails 248, 250 can be modified.For example, where the cores 10 have a land 22, the inner corners neednot be rounded, but rather, they may be 90-degree corners 256′, 258′ (asshown in FIG. 24D).

With reference now to FIGS. 24A-24C and 25A-25C, the operation of thecore dispensing apparatus 230, and especially the positioning slat 238and plunger 240, will now be described. It is noted that FIGS. 24A-24Cshow the positioning slat 238, the plunger 240, the film 138 and cores10′, 10″, as viewed from the position of line Q—Q in FIG. 22 and lookingin the direction of the arrows. FIGS. 25A-25C show side views of aportion of the positioning slat 238, as well as the plunger 240, thefilm 138, and cores 10′, 10″, as seen from within the positioning slat238 (i.e., as if the nearest wall 244 and corresponding support rail 248were eliminated).

During continuous operation, which is the preferred mode of operation inaccordance with the third embodiment of the present invention, the cores10 are fed from the hopper 232, through the slat feeders 234, 236, tothe positioning slat 238, in a known manner. As they are fed into thepositioning slat 238, the cores 10′, 10″, 10′″ are lined up, end 12 toend 14, as shown in FIGS. 25A-25C and 26, and, thereby, each core 10′,10″, 10′″ is moved along the positioning slat 238 in a substantiallycontinuous manner by the core behind it.

When a core 10′ is pushed beyond the support rails 248, 250 and is nolonger supported thereby, and when the position of a color transition186 of the film 138 lies in the conjugate plane of symmetry 18′ of thecore 10′, the registering means 242 signals the motor (not shown), whichthe moves the plunger 240 in the direction shown by the arrows R, R′ inFIGS. 24A and 25A, respectively. The plunger 240 moves in the directionof the arrows R, R′ until the core 10′ contacts and rests upon the film138 (see FIGS. 24B and 25B), whereupon the plunger 240 momentarily stopsits descent and is then moved in the opposite direction, shown by thearrows S, S′ in FIGS. 24B and 25B, respectively. When the plunger 240reaches its upmost position, as shown in FIGS. 24C, 25C, it momentarilystops, until the next core 10″ is moved beyond the support rails 248,250. The foregoing events are repeated continuously as long as cores 10are fed and moved through the positioning slat 238.

With reference now, in particular, to FIGS. 26-30, the remainingcomponents of the alternative enrobing apparatus of the thirdembodiment, as well as their operation, will now be described. Moreparticularly, FIG. 26 shows a schematic perspective view of thepositioning slat 238, the conveyor system 220 having specialized rollers222 and pairs of rollers 224, 226, 228 and a pair of rotary dies 260,262. It is noted that the rotary dies 260, 262 are similar, but notidentical, to the rotary dies 112, 112′, 208, 208′ of the first andsecond embodiments discussed earlier hereinabove. As seen in FIG. 26,the rollers 222 and the pairs of rollers 224, 226, 228 of the conveyorsystem 220 are arranged side-by-side.

More particularly, the beginning portion of the conveyor system 220,i.e., the portion that is located between the alternative film castingapparatus 136 (shown only partially in FIG. 22, see FIG. 17 for fullview) and a short distance on the opposite side of the core positioningslat 238 (see FIG. 26), is comprised of horizontally-oriented rollers222. FIG. 27 shows an elevational end view of a core 10, the film 138and a horizontally-oriented roller 222, in their relative positions toone another, as seen from the position of line T—T in FIG. 26 andlooking in the direction of the arrows.

The film 138 is moved by the horizontally-oriented rollers 222 (see FIG.22), from the alternative film casting apparatus 136 to a short distancepast the positioning slat 238 and plunger 240, by which cores 10 havealready been deposited onto the film 138, as described hereinabove. Itis noted that the horizontally oriented rollers 222 should be at leastas long as the width of the film 138, to ensure sufficient support forthe film 138. The horizontally-oriented rollers 222 may spin about theirlongitudinal axes 264 in the direction shown by the arrow U in FIG. 27.

As shown in FIG. 26, the remaining portion of the conveyor system 220,which is located between a short distance past the positioning slat 238and the rotary dies 260, 262, is comprised of pairs of rollers 224, 226,228, rather than the horizontally-oriented rollers 222. As shownschematically in FIG. 26, the individual rollers of sequential pairs ofrollers 224, 226, 228 are gradually and sequentially pivoted upward fromthe horizontal plane, in increments of about 10 degrees for eachsuccessive pair of rollers 224, 226, 228, starting proximate to thepositioning slat 238, such that, as the film 138 approaches the rotarydies 260, 262, the film 138 is folded longitudinally about the cores 10.

More particularly, the individual rollers 224 a, 224 b of the pairs ofrollers 224 that are located proximately to the positioning slat 238 arepivoted upward a small amount, i.e., about 30 degrees (see FIG. 28showing the degree to which the individual rollers 224 a, 224 b at thislocation are pivoted, as seen approximately from the position of lineV—V in FIG. 26 and looking in the direction of the arrows). As shown inFIG. 28, the individual rollers 224 a, 224 b in these pairs 224 may eachspin about their longitudinal axes 266 a, 266 b in the directionsindicated by the arrows Wa, Wb.

By comparison, the individual rollers 226 a, 226 b of the pairs ofrollers 226 that are located further from the positioning slat 238 arepivoted upward by a greater amount, i.e., about 70 degrees (see FIG. 29showing the degree to which the individual rollers 226 a, 226 b at thislocation are pivoted, as seen from the position of line X—X in FIG. 26and looking in the direction of the arrows). As shown in FIG. 29, theindividual rollers 226 a, 226 b in these pairs 226 each spin about theirlongitudinal axes 268 a, 268 b in the directions indicated by the arrowsYa, Yb.

Lastly, as shown in FIGS. 26 and 30, the individual rollers 228 a, 228 bof the pairs of rollers 228 which are proximate to the rotary dies 260,262 are configured differently from the other individual rollers 224 a,224 b, 226 a, 226 b. More particularly, the individual rollers 228 a,228 b of these pairs of rollers 228 each have a concave central portion270 a, 270 b which cooperate to form an opening 272 therebetween that issized and shaped to allow the film 138 and cores 10 to pass snuglytherethrough.

Each individual roller 228 a, 228 b also has a cylindrical upper portion274 a, 274 b which cooperate with one another to press the longitudinaledges 276, 278 of the film 138 against one another (see FIG. 30),thereby bonding the longitudinal edges 276, 278 of the film 138 to oneanother prior to passing through the rotary dies 260, 262. FIG. 30 showsthat the individual rollers 228 a, 228 b of the pairs of rollers 228 atthis location are oriented substantially vertically, as seen from theposition of line Z—Z in FIG. 26 and looking in the direction of thearrows. As also shown in FIG. 30, the individual rollers 228 a, 228 b ofthese pairs of rollers 228 may each rotate about their longitudinal axesa 280 a, 280 b in the directions indicated by the arrows AAa, AAb.

It is noted that different configurations are possible for theindividual rollers 224 a, 224 b, 226 a, 226 b, 228 a, 228 b and thepairs of rollers 224, 226, 228, for example, one roller 224 a, 226 a,228 a in each pair could be horizontally positioned and remainstationary, while the other roller 224 b, 226 b, 228 b in each pair ispivoted. In addition, depending upon the support requirements of thefilm 138, greater or fewer numbers of horizontally-oriented rollers 222and pairs of rollers 224, 226, 228 may be used for the conveyor system220 and they may be spaced more closely or further apart than shown inthe accompanying figures.

The rotary dies 260, 262 of the third embodiment of the presentinvention, shown in FIG. 26, are similar to the rotary dies 112, 112′,208, 208′ of the first and second embodiments in that they rotate in thedirections indicated by the arrows BB and CC, respectively, in FIG. 26,thereby cooperating with one another to form a nip therebetween, intowhich the cores 10 and the film 138 are fed. Likewise, each of the dies260, 262 have recesses 282, 284, arranged circumferentially in a row onthe surface of each die 260, 262. The recesses 282, 284 each have raisedrims (not shown) for sealing and cutting the bonded film 138 about thecores 10, thereby enrobing the cores 10 to form gelcap products 286.

The rotary dies 260, 262 of the third embodiment, however, are orientedsuch that they rotate in the horizontal plane, rather than in thevertical plane as do the previously discussed rotary dies 112, 112′,208, 208′. Furthermore, when the cores 10 are fed into the nip betweenthe dies 260, 262 of the third embodiment, the film 138 is folded andpartially bonded about them. Furthermore, the partially enrobed caplets10 are fed successively, i.e., one-by-one, into the nip between the dies260, 262.

The gelcap products 286 of the third embodiment are similar to the isgelcaps 122, 214 of the previous embodiments, in that they are gelcaps286 having at least two visually distinct, or differently colored,portions and having film seams 288 which are transversely orientedrelative to the color transitions 290 (or other visual distinctiontransitions) of the gelcaps 286. More particularly, the film seam 288lies in the transverse plane of symmetry 16 of the core 10 and the colortransition 290 lies in the conjugate plane of symmetry 18 of the core10. In addition, in, contrast to gelcaps produced by apparatus andmethods of the prior art, the color transition 290 of the gelcap 286 ofthe third embodiment may be flush and seamless, i.e., without any raisedportion which generally characterizes the film seam 288 of gelcaps.Moreover, the gelcaps 286 may have a film coating of uniform colorquality and thickness over their entire surface. It is noted, however,that unlike the gelcaps 122, 214 of the previously describedembodiments, the film seams 288 of the gelcaps 286 that are produced bythe apparatus and process of the third embodiment extend only partiallyabout the cores 10. If aesthetically desired, the film 138 may overlapslightly at its edges along the film seam 288.

As will be appreciated by those persons with ordinary skill andexperience in the present field, it is possible to substitute otherknown, conventional cutting devices in place of the rotary dies 260, 262shown in FIG. 26. For example, die punches (not shown), or reciprocatinguniplasts (not shown), having recesses or cutouts that are sized andshaped to receive therein the partially enrobed caplets 10 could beused. Such devices are commercially available from various sources,including, but not limited to, The Irwin-Hodson Company of PortlandOreg., and are well-known to those having ordinary skill in the art. Inaddition, alternative reciprocating cutting apparatus which relates toproducing enrobed capsule products is disclosed in U.S. Pat. No.6,352,719, which is hereby incorporated by reference herein.

With reference to the movement of the transversely striped film 138along the conveyor system 220 of horizontally-oriented rollers 222 andpairs of rollers 224, 226, 228, it is noted that the film 138 isencouraged to move, continuously and at a substantially constant speed,in the direction of the arrow DD in FIG. 26, by the nip between therotary dies 260, 262 and the momentum of the horizontally-orientedrollers 222 and the pairs of rollers 224, 226, 228 as they spin abouttheir axes. Alternatively, or in addition thereto, one or more of thehorizontally-oriented rollers 222 and the pairs of rollers 224, 226, 228could be mechanized by conventional motors (not shown) to spinautonomously, thereby encouraging the film 138 to move along theconveyor system 220 toward the rotary dies 260, 262.

With reference to the stock film forming material that is used inconnection with the foregoing alternative core enrobing apparatus of thethird embodiment, when it is either thermoplastic starch-based materialor cellulose-based material, as suggested hereinabove, the transverselystriped film 138 must be heated prior to being advanced along theportion of the conveyor system 220 that is comprised of pivoted pairs ofrollers 224, 226, 228 to ensure that the film 138 is sufficientlyformable and malleable to be folded about the caplets 10 by the pairs ofrollers 224, 226, 228, while maintaining its physical integrity. In suchcircumstances, the film 138 can be heated by conventional heating means,such as, for example, a resistive heating device (not shown) which wouldheat the film 138 indirectly by heating selected horizontally-orientedrollers 222 and pairs of rollers 224, 226, 228, or hot air blowers (notshown) which could heat the film 138 directly by blowing hot airthereon. Suitable heaters are commercially available, for example, fromChromolox, Inc. of Pittsburgh, Pa. and Watlow Electric ManufacturingCompany of St. Louis, Mo. Suitable hot air blowers are commerciallyavailable, for example, from New York Blower Company of Willowbrook,Ill. and Niagara Blower Company of Buffalo, N.Y.

More particularly, where the film 138 is made of starch-based material,the film 138 should be heated to between about 50 degrees Celsius andabout 150 degrees Celsius and where the film 138 is made ofcellulose-based material, the film 138 should be heated to between about80 degrees Celsius and about 120 degrees Celsius.

The fourth embodiment of the present invention, which relates to avacuum forming apparatus and method of enrobing cores is generallyillustrated in FIGS. 31-43. It is noted that, while various types ofthermal formable films, including films made of the previously discussedgelatin-, starch- and polymer-based materials, may be used in connectionwith the fourth embodiment of the present invention, films made ofcellulose ether-based materials, e.g. hydroxypropyl methylcellulose, arethe preferred films to be used in connection with the apparatus andmethod described hereinafter. However, while the composition of the filmmay be the same or similar to that of the films discussed hereinabove,the film that is used in connection with the apparatus of the fourthembodiment is pre-manufactured as a dry film, rather than the wet filmsthat were described previously in connection with the first, second andthird embodiments.

More particularly, to produce films that are suitable for use with thevacuum forming apparatus of the fourth embodiment, the wet films of theprevious embodiments are subjected to a further drying step, whichinvolves heating the film, in a manner that is well-known to the art offilm forming, to a temperature such that the film remains pliable, butno longer automatically bonds to itself upon contact. The dried film isthen mounted onto rollers, as shown and described hereinafter inconnection with FIG. 31. In addition, the dry films used in this fourthembodiment may also be subjected to further processing steps, including,but not limited to, the addition of humectants or plasticizers, such asglycerin or sorbitol, for the purpose of enhancing the elasticity andformability of the dry films. For example, from 0.1 to 10 weight percentof humectants, based upon the total weight of the dry film material,could be added to the dry films. In addition, from 5 to 50 weightpercent of plasticizers, based upon the total weight of the dry filmmaterial, could be added to the dry films. It is also noted that, asdiscussed hereinafter, striped films having stripes that are eitherlongitudinally or transversely oriented may be used in connection withthe apparatus and method of the fourth embodiment, which will now bedescribed in detail. Films having a thickness of between about 0.01millimeters and about 0.5 millimeters are most suitable for use inconnection with this fourth embodiment of the present invention.

With reference, in particular, to FIG. 31, a schematic elevational sideview is provided of the vacuum forming apparatus 292 of the fourthembodiment. More particularly, the vacuum forming apparatus 292 includesa first plurality of individual porous platens 294, as well as a firstconveyor system 296 and a second conveyor system 298. As shownschematically in FIG. 31, the first and second conveyor systems 296, 298are arranged in series with one another, thereby creating a single path,indicated by the arrows EE, FF, along which the first and secondconveyor systems 296, 298 move each of the porous platens 294 insemi-continuous fashion. For purposes of illustration only, the firstand second conveyor systems 296, 298 are shown schematically in FIG. 31mounted on tables 296′, 298′. In addition, the first and second conveyersystems 296, 298 are provided with conventional vacuum sources 300, 302,respectively, (shown only schematically in FIG. 31) that apply a vacuumto each of the porous platens 294 while they are moved in the directionshown by the arrow EE, for a purpose to be discussed hereinafter.Suitable conventional vacuum sources, such as vacuum pumps, would becommercially available from, for example, The Nash Company of Trumbull,Conn. and Gast Manufacturing of Benton Harbor, Mich.

It is noted that the first and second conveyor systems 296, 298 eachinclude a conveyor mechanism, such as a conventional chain track (notshown) or other conventional mechanism of a type that is known in theart. More particularly, conveyor systems suitable for use in connectionwith the vacuum forming apparatus 292 of the present invention aretypically custom manufactured and persons having ordinary skill in theart will be familiar with the basic configuration and operation of suchdevices. Suitable conveyor systems are currently commercially availablefrom, for example, Dorner of Hartland, Wis.

With reference still to FIG. 31, the vacuum forming apparatus 292further includes a second plurality of individual porous platens 304 anda third conveyor system 306 that moves these porous platens 304 along asecond path, which is shown by the arrow GG in FIG. 31. It is noted thatthe third conveyor system 306 is positioned between the first and secondconveyor systems 296, 298 for a purpose that is clarified hereinafter.

A rotating mechanism 308 (shown only schematically in FIG. 31) ispositioned between the first and second conveyor systems 296, 298. Therotating mechanism 308 is a conventional device and well known topersons having ordinary skill in the art. The rotating mechanism 308 isdesigned to simultaneously hold together two of the platens, i.e., oneplaten 294 and a corresponding platen 304, and rotate them together,such that the platen 304 that is first on top is inverted and thenpositioned on the bottom after the rotation is completed. The aforesaidrotation will be described in further detail hereinafter.

Except for their opposite orientations, the porous platens 294, 304 areessentially identical to one another. More particularly, as shown inphantom in certain of the porous platens 294, 304 in FIG. 31, eachporous platen 294, 304 has at least one recess 310, 312, respectively,on a working surface 314, 316, respectively, thereof. Each recess 310,312 is sized and shaped to temporarily but snugly receive therein acaplet 10 to be enrobed. With reference to FIGS. 33 and 35, it is notedthat, although the porous platens 294, 304 are shown in FIG. 31 as eachhaving a single longitudinally oriented recess 310, 312, it is notedthat the porous platens 294, 304 may be configured to each have aplurality of recesses 310, 312. For example, the platens 294, 304 couldeach be long enough to include a single row of recesses 310, 312, or, asshown in FIGS. 33 and 35, each platen 294 a, 294 b could be long andwide enough to have multiple rows of recesses 310 a, 310 b.

In addition, it is noted that, if the orientation of the recesses 310 a,310 b of the platens 294 a, 294 b is varied, the use of differentlystriped films can be accommodated, as follows. With reference to FIGS.32 and 33, where the recesses 310 a are oriented longitudinally on theworking surface 314 a of the porous platen 294 a (see FIG. 33) it ispossible to use a striped film 318 having alternating colors or visualdistinctions, e.g., red and yellow transverse stripes 320, 322 (see FIG.32), to produce gelcap products having a color transition (or othervisual distinction transition) that lies in the conjugate plane ofsymmetry 18 of the core 10. The resulting product would resemblegelpcaps 122, 214, 286 produced in connection with the previouslydiscussed embodiments of the present invention. In FIGS. 32 and 33, thetransversely striped film 318 is shown suspended above the platen 294 ain the proper position relative to the recesses 310 a, such that thecolor transitions 324, 326 between the transverse stripes 320, 322 areproperly aligned with the recesses 310 a to result in the production ofthe aforesaid bi-colored enrobed core products.

With reference to FIGS. 34 and 35, on the other hand, it is possible forthe recesses 310 b to be oriented transversely on the working surface314 b of the porous platen 294 b (see FIG. 35) to accommodate the use ofa striped film 328 having alternating colors or visual distinctions,e.g., red and yellow longitudinal stripes 330, 332 (shown in FIG. 34),to produce gelcap products having a color transition lying in theconjugate plane of symmetry 18 of the core 10. In FIGS. 34 and 35, thelongitudinally striped film 328 is shown suspended above the platen 294b in the proper position relative to the recesses 310 b, such that thecolor transitions 334, 336 between the longitudinal stripes 330, 332 areproperly aligned with the recesses 310 b to result in the is productionof the aforesaid bi-colored caplet products.

It is of course possible to achieve multi-colored gelcap products havingcolor transitions oriented in a variety of different ways usingdifferent combinations of the platens 294 a, 294 b shown in FIGS. 33 and35, with transversely and longitudinally striped films 318, 328, shownin FIGS. 32 and 34. In this regard, however, it is noted that, within aparticular vacuum forming apparatus, the orientation of the recesses310, 312 in all of the platens 294, 304 must be longitudinal, or,alternatively, the orientation of the recesses 310, 312 in all of theplatens 294, 304 must be transverse (or otherwise aligned with theorientation of the stripes on the films).

With reference again to FIG. 31, the vacuum forming apparatus 292further includes a first pair of rollers 338, 340 having a first stripedfilm 342 mounted thereon. As shown in FIG. 31, the first pair of rollers338, 340 is positioned proximate to the first conveyor system 296 suchthat the first striped film 342 is suspended above the first pluralityof porous platens 294, which are being moved thereon along the pathshown by the arrow EE. A second pair of rollers 344, 346 having a secondstriped film 348 mounted thereon is also provided. Like the first pairof rollers 338, 340, the second pair of rollers 344, 346 is positionedproximate to the second conveyor system 298 such that the second stripedfilm 348 is also suspended above the first plurality of porous platens294, which are being moved thereon along the path shown by the arrow EE.

It is noted that, in order to produce gelcaps having a color transition,or transition between other visually distinct portions of the enrobedcore 10, that lies in the conjugate plane of symmetry 18 of the core 10using platens 294 a like those of FIG. 33 (i.e., all havinglongitudinally oriented recesses 310 a), both the first and secondstriped films 342, 348 must have transversely oriented stripes 320, 322,as shown in FIG. 32. Similarly, in order to produce bi-colored gelcapsstill having a color transition that lies in the conjugate plane ofsymmetry 18 of the caplet 10 using platens 294 b like those of FIG. 35(i.e., all having transversely oriented recesses 310 b), it would benecessary for both the first and second striped films 342, 348 to havelongitudinally oriented stripes, as shown in FIG. 34.

The above-described variations concerning the orientation of therecesses 310, 312 on the platens 294, 304 and the orientation of thestripes on the first and second films 342, 348 are all equally valid.However, for purposes of illustrating the fourth embodiment of thepresent invention in as simple and clear a manner as possible,henceforth, it will be understood that the platens 294, 304 of thevacuum forming apparatus 292 each have a single longitudinally orientedrecess 310, 312 thereon. Furthermore, it will henceforth also beunderstood that the first and second striped films 342, 348 both havealternating red and yellow stripes that are transversely oriented.

As shown in FIG. 31 and discussed in further detail hereinafter, thevacuum forming apparatus 292 also includes a first registering device350 positioned proximate to the first conveyor system 296 for properlypositioning the first transversely striped film 342 relative to a core10 that is positioned within the recess 310 of the porous platen 294, aswill be described hereinafter. A second registering device 352 ispositioned proximate to the second conveyor system 298 for properlypositioning the second transversely striped film 348 relative to apartially enrobed caplet 10 that is positioned within the recess 310 ofanother of the porous platens 294, as will be described hereinafter. Theregistering devices 350, 352 are of the same commercially available typeas were described previously above in connection with the firstembodiment of the present invention.

As shown in FIGS. 31, 36-38 and 41-43, the vacuum forming apparatus 292of the fourth embodiment also includes a first ring press 354 and afirst film cutter 356 that are positioned proximate to the firstconveyor system 296, for purposes that will be clarified hereinafter.Additionally, a second ring press 358 and a second film cutter 360 arepositioned proximate to the second conveyor system 298, also forpurposes that will be clarified hereinafter. More particularly, withreference to FIGS. 36-37 and 41-42, the first and second ring presses354, 358 are virtually identical to one another, each having an openconfiguration, such as an O-shape or an oval shape, as viewed fromabove, such that there is formed a passageway 362, 364, respectively,therethrough. Each of the ring presses 354, 358 also has a contactingedge 366, 368, respectively, that is configured to contact the first andsecond films 342, 348, respectively, without damaging them. Each of thering presses 354, 358 is sized and shaped such that the contacting edges366, 368 circumscribe a core 10 therein. The first and second ringpresses 354, 358 move reciprocatingly in the directions shown by thearrows HH, II, respectively, in FIG. 31.

With reference, in particular, to FIGS. 38 and 43, the first and secondfilm cutters 356, 360 are virtually identical to one another, eachhaving a recess 370, 372, respectively, that is sized and shaped toreceive therein a portion of a partially enrobed core 10 which alreadyhas a film coating applied thereto. Each recess 370, 372 iscircumscribed by a tapered cutting edge 374, 376 that is sized andshaped to closely circumscribe the periphery of the aforesaid partiallyenrobed core 10 and is capable of cutting neatly and cleanly through thefirst and second transversely striped films 342, 348, respectively. Thefirst film cutter 356 is oriented such that its recess 370 and cuttingedge 374 both face the porous platen 294 positioned thereunder.Similarly, the second film cutter 360 is oriented such that its recess372 and cutting edge 376 also both face the porous platen 304 positionedthereunder. Also, like the ring presses 354, 358, the first and secondfilm cutters 356, 360 move reciprocatingly in the directions shown bythe arrows HH, II in FIG. 31.

With reference still to FIG. 31, it is noted that the first transverselystriped film 342 is mounted onto a first pair of rollers 338, 340 andstretched therebetween, such that the first film 342 is positionedbetween the first conveyor system 296 and the first plurality of porousplatens 294 on one side, and the first ring press 354 and the first filmcutter 356 on the other side. Similarly, the second transversely stripedfilm 348 is mounted onto a second pair of rollers 344, 346 and stretchedtherebetween, such that the second film 348 is positioned between thesecond conveyor system 298 and the first plurality porous platens 294 onone side, and the second ring press 360 and the second film cutter 362on the other side.

As will be referred to subsequently herein, in connection with thedescription of the method of the fourth embodiment, the vacuum formingapparatus 292 shown in FIG. 31 includes at least seven stations 378,380, 382, 384, 386, 388, 390 (shown in dotted lines in FIG. 31), each ofwhich is shown in further detail in FIGS. 36-43. The aforesaid stations378, 380, 382, 384, 386, 388, 390 show the general locations of the ringpresses 354, 358, and the film cutters 356, 360, relative to the othercomponents of the vacuum forming apparatus 292. The stations 378, 380,382, 384, 386, 388, 390 also provide a conceptual representation of theseven basic steps of the method of the fourth embodiment.

The operation of the vacuum forming apparatus 292 and the method of thefourth embodiment of the present invention will now be described indetail, with reference to FIGS. 31 and 36-44. In this regard, it isnoted that FIGS. 36-44 show elevational cross-sectional views of certaincomponents of the vacuum forming apparatus 292. More particularly, thecross-sections of the platens 294, the first ring press 354 and thefirst film cutter 356 shown in FIGS. 36-39 are taken along cross-sectionline JJ—JJ of FIG. 31 and are viewed from the same direction as whenviewing the vacuum forming apparatus 292 shown in FIG. 31. Thecross-sections of the platens 304, the second ring press 358 and thesecond film cutter 360 shown in FIGS. 40-43 are taken alongcross-section line KK—KK of FIG. 31 and are also viewed from the samedirection as when viewing the vacuum forming apparatus 292 shown in FIG.31. It is further noted that the conveyor systems 296, 298, theregistering devices 350, 352 and the vacuum sources 300, 302 are omittedfrom FIGS. 36-43 to simplify the description of the operation of thevacuum forming apparatus 292, by which cores 10 are enrobed with thefirst and second transversely striped films 342, 348.

Initially, the first, second and third conveyor systems 296, 298, 306are set into motion, thereby moving the porous platens 294, 304 in thedirections indicated by the arrows EE, FF, GG, respectively, in FIG. 31.The vacuum sources 300, 302 are also activated, thereby applyingvacuums, in the range of about 0.005 Torr to about 700 Torr, to thefirst and second conveyor systems 296, 298, and, thereby in turn, toeach of the first plurality of porous platens 294 that is being moved inthe direction of the arrow EE.

More specifically, with reference initially to FIG. 31, the firstconveyor system 296 moves one of the porous platens 294 to a positionthat is immediately prior to the first station 378. A core 10 is placedinto the recess 310 of this porous platen 294 by a core dispensingmechanism (not shown). It is noted that the core dispensing mechanism ofthis fourth embodiment can be any one of conventional, well-known coredispensing mechanisms, such as those described previously in connectionwith the first, second and third embodiments. The core 10 is held firmlyin the recess 310 by the aforementioned vacuum, which is continuouslyapplied to the platen 294 and all others on the conveyor 298, by thefirst vacuum source 300.

With reference now to both of FIGS. 31 and 36, the platen 294 is nextmoved by the first conveyor system 296 to the first station 378.Movement of the platen 294 ceases temporarily when the first registeringdevice 350 (see FIG. 31) confirms that the core 10 is properlypositioned relative to the first striped film 342, i.e., such that thecolor transition 392 of the first striped film 342 (see FIG. 36) lies inthe conjugate plane of symmetry 18 of the core 10.

While the platen 294 is momentarily stationary, hot air is blown, byconventional, well-known means, such as a combined coil heater and fandevice (not shown), through the passageway 362 of the first ring press354, in the direction shown by the arrows LL in FIG. 36, therebysoftening the first film 342 to a formable state. The hot air should,preferably, be in the range of between about 50 degrees Celsius andabout 300 degrees Celsius, depending upon the type of film used. Thefirst ring press 354 is then moved in the direction shown by the arrowMM in FIG. 36, such that the contacting edge 366 of the first ring press354 presses the first film 342 onto the working surface 314 of theplaten 294 and into contact with the top half of the core 10.

As shown in FIG. 37, the heated first film 342 is simultaneously pulledonto the core 10 and thereby made to conform to the shape of the tophalf of the core 10 by the aforementioned vacuum that is applied to theplaten 294 by the first vacuum source 300. The vacuum applied by thefirst vacuum source is in the aforesaid range of about 0.005 Torr toabout 700 Torr. Thereafter, the first ring press 354 is moved away fromthe platen 294, in the direction shown by the arrow NN in FIG. 37, whilethe heated first film 342 is held onto the core 10 by the aforesaidvacuum.

With continued reference to FIG. 37, after the first ring press 354 isretracted, the platen 294, having the partially enrobed core 10 held inits recess 310 by the vacuum, is moved to the second station 380 of thevacuum forming apparatus 292, where it is temporarily stopped. While theplaten 294 and the core 10 are temporarily stationary, cold air is blownonto the first film 342 and core 10 in the direction shown by the arrowsLL in FIG. 37, thereby cooling and molding the first film 342 intoconformity with the top half of the core 10. The cold air should be at atemperature that is sufficiently cool to stiffen the film 342 such thatit retains its shape in conformity with the shape of the core 10, moreparticularly between about −10 degrees Celsius and about 25 degreesCelsius.

With reference now to FIG. 38, after sufficient time has passed to cooland mold the first film 342 onto the core 10, the platen 294 andpartially enrobed core 10 are moved a predetermined distance by thefirst conveyor system 296 to the third station 382 of the vacuum formingapparatus 292 and temporarily halted there such that the partiallyenrobed core 10 is aligned with the recess 370 and the cutting edge 374of the first film cutter 356. As shown in FIG. 38, the first film cutter356 is moved in the direction of the arrow OO until the partiallyenrobed core 10 is received snugly within the recess 370 and the taperedcutting edge 374 contacts and cuts through the first film 342 closelyaround the perimeter of the partially enrobed core 10. The first filmcutter 356 is then moved away from the platen 294 in a directionopposite the direction indicated by the arrow OO and scrap portions 394,396 of the first film 342 are removed from the platen 294.

With reference now to FIGS. 39 and 40, the platen 294 and partiallyenrobed core 10 are next moved to the fourth, or rotating, station 384of the vacuum forming apparatus 292 and, again, temporarily stopped,whereupon the partially enrobed core 10 is transferred to one of theplatens 304, as follows. As shown in FIG. 39, the third conveyor system306 moves one of the platens 304 into position at the rotating station384, such that it 304 is inverted relative to the platen 294 carryingthe partially enrobed core 10 thereon. It is noted that the workingsurfaces 314, 316 of the platens 294, 304 are facing one another (seeFIGS. 31, 39 and 40). After the platen 294 is moved a predetermineddistance, such that the partially enrobed core 10 is aligned with therecess 312 of the inverted platen 304, the first conveyor system 296holds the platen 294 and partially enrobed core 10 temporarilystationary at the rotating station 384. The platen 304 is then movedtoward the partially enrobed core 10 (i.e., in the direction shown bythe arrow PP in FIG. 39) until the partially enrobed core 10 is heldwithin the recesses 310, 312 of both of the platens 294, 304 (as shownin FIGS. 31 and 40). The vacuum being applied to the porous platen 294is discontinued and the rotating mechanism 308 (shown schematically inFIG. 31) rotates the platens 294, 304, with the partially enrobed core10 therebetween, in the direction shown by the arrows QQ, QQ′ in FIGS.31 and 40, whereupon the platen 294 holding the core 10 is inverted, andthe platen 304 is moved into a right-side-up position. The now invertedplaten 294 is now moved away from the right-side-up platen 304 andbecomes one of the platens 304 moving along the path shown by the arrowGG in FIG. 31. The right-side-up platen 304 is next moved onto thesecond conveyor system 298 and becomes one of the platens 294 movingalong the path shown by the arrows EE, FF in FIG. 31. Next, the secondvacuum source 302 applies a vacuum, in the aforesaid range of about0.005 Torr to about 700 Torr, to the partially enrobed core 10, therebyholding the partially enrobed core 10 within the recess 310 of theplaten 294, which is now moving on the second conveyor system 298, suchthat the uncovered portion of the partially enrobed core 10 is exposed.

FIGS. 41-43 show, schematically, the method by which the uncoveredportion of the core 10 is covered by the second transversely stripedfilm 248. More particularly, with reference in particular to FIG. 41,the platen 294 and partially enrobed core 10 are moved by the secondconveyor system 298 to the fifth station 386 of the vacuum formingapparatus 292. Movement of the platen 294 ceases temporarily when thesecond registering device 352 (see FIG. 31) confirms that the partiallyenrobed core 10 is properly positioned relative to the second stripedfilm 248, i.e., such that the color transition 398 of the second stripedfilm 348 (see FIG. 41) lies in the conjugate plane of symmetry 18 of thepartially enrobed core 10.

While the platen 294 is momentarily stationary, hot air is blown, byconventional, well-known means, such as a combined coil heater and fandevice (not shown), through the passageway 364 of the second ring press358, in the direction shown by the arrows RR in FIG. 41, which softensthe second film 348 to a formable state. The hot air is preferably inthe aforesaid range of about 50 degrees Celsius to about 300 degreesCelsius. The second ring press 358 is then moved in the direction shownby the arrow SS in FIG. 41, such that the contacting edge 368 of thesecond ring press 358 contacts and presses the second film 348 onto theworking surface 314 of the platen 294 and into contact with theuncovered portion of the partially enrobed core 10.

As shown in FIG. 42, the heated second film 248 is then pulled onto thecore 10 by the vacuum that is applied by the second vacuum source 302(see FIG. 31), in the aforesaid range of about 0.005 Torr to about 700Torr, to the platen 294, thereby conforming the second film 248 to theshape of the uncovered portion of the core 10. Thereafter, the secondring press 358 is moved away from the platen 294, in the direction shownby the arrow TT in FIG. 42, while the heated second film 248 is heldonto the core by the aforesaid vacuum applied by the second vacuumsource 302.

With continued reference to FIG. 42, after the second ring press 358 isretracted, the platen 294, having the enrobed core 10 held in its recess310 by the vacuum, is now moved to the sixth station 388 of the vacuumforming apparatus 292 and temporarily stopped there. It is noted that,as shown in FIG. 42, the second film 348 partially overlaps the cut edgeof the first film 342 that has already been applied to the core 10.While the platen 294 and the core 10 are temporarily stationary, coldair, in the aforesaid range of about −10 degrees Celsius to about 25degrees Celsius, is now blown onto the second film 248 and core 10 inthe direction shown by the arrows RR in FIG. 42, thereby cooling andmolding the second film 348 into conformity with the core 10.

With reference now to FIG. 43, after sufficient time has passed to cooland mold the second film 348 onto the core 10, the platen 294 and theenrobed core 10 are moved a predetermined distance by the secondconveyor system 298 to the seventh station 390 of the vacuum formingapparatus 292 and temporarily halted there such that the enrobed core 10is aligned with the recess 372 and the cutting edge 376 of the secondfilm cutter 360. As shown in FIG. 43, the second film cutter 360 ismoved in the direction of the arrow UU until the enrobed core 10 isreceived snugly within the recess 372 and the cutting edge 376 contactsand cuts through the second film 248 closely around the perimeter of theenrobed core 10. The second film cutter 360 is then moved away from theplaten 294 in a direction opposite the direction indicated by the arrowUU in FIG. 43.

As shown in FIG. 44, scrap portions 400, 402 of the second film 344 areremoved from the platen 294. The platen 294 and fully enrobed core 10are moved by the second conveyer system 298 away from the seventhstation 390. After the platen 294 and enrobed core 10 are past theseventh station 390, the vacuum being applied to the platen 294 isceased, thereby releasing the enrobed caplet product, or gelcap 404 fromthe recess 310.

As shown in FIG. 44, the resulting gelcaps 404 have film coatings thatconform tightly and snugly to the cores 10. It is noted that, in orderto form a tamper-proof seal between the first and second films 342, 348and the core 10, an adhesive, such as a liquid form of the stockmaterial, can be applied to the surfaces 406, 408 (see, e.g., FIGS. 36and 41) of each of the first and second films 342, 348 that will contactthe caplet 10. In addition, like the gelcaps 122, 214, 286 produced bythe first, second and 26 third embodiments of the present invention, thegelcaps 404 produced by the vacuum forming apparatus 292 and method ofthe fourth embodiment are bi-colored, or have at least two visuallydistinct regions, having a film seam 410 between the film coatings thatlies substantially in the transverse plane of symmetry 16 of the core10, and a color transition 412 between the colors, or other visuallydistinct regions, that lies substantially in the conjugate plane ofsymmetry 18 of the core 10. In addition, the color transition 412 of thegelcap 404 may be flush and seamless, i.e., without any raised portionwhich generally characterizes the film seam 410. In addition, theforegoing process results in gelcap products 404 having a film coatingof uniform color quality and thickness over their entire surface. Ifaesthetically desired, the first and second films 342, 348 may beapplied to the core 10 such that the resulting gelcaps 404 have a filmseam 410 wherein a stripe of one color or visual distinction (forexample, a red stripe) of one film 342 abuts or overlaps a stripe ofanother color or visual distinction (for example, a yellow stripe) ofthe other film 348 to form a gelcap 404 having a “checkerboard pattern”(not shown), i.e., having four quadrants of alternating red and yellowcolors or other visual distinctions.

Although not shown in figures, an alternative to the apparatus andmethod of the fourth embodiment will now be described. The alternativeapparatus would include platens having recesses that are each becircumscribed by a raised cutting ridge capable of cleanly cutting thefirst and second films 342, 348. In a further alternative method thatmay be practiced with the aforesaid apparatus, instead of first placingthe caplet 10 into the recess 310 of the first platen 294, the firstfilm 342 would be laid across a first platen and then warm air would beblown onto the first film 342 to soften it to a formable state. Then, avacuum would be applied through the platen to pull the first film 342into the recess and conform it thereto. Thereafter, the core 10 would beplaced into the recess 310 and cool air blown onto the platen 294, firstfilm 342 and core, to mold the first film 342 into conformity with thecore 10. The second film 348 would then be placed onto the platen, ontop of the core 10, and warm air blown onto the second film 348 tosoften it to a formable state. Another platen (not shown) would then bemoved into contact with the second film 348, pressing the second film348 against the core 10 and the first platen 294, thereby, conformingthe second film 348 to the contour of the caplet 10. Cool air is thenblown onto the second film 348, thereby molding the second film 348 ontothe caplet 10. It is noted that the hot and cold air temperature ranges,as well as the vacuum pressure range, are the same as previously statedhereinabove in connection with the description of the fourth embodimentof the present invention. Lastly, the raised cutting edges of therecesses cut through both of the first and second films 342, 348,thereby releasing enrobed gelcap products each of which have a film seamthat is transverse to the color transition (or visual distinctiontransition) of the gelcaps.

The cores 10 that are suitable for use with the apparatus and methods ofthe present invention are mass produced and well-known by those havingordinary skill in the art. The cores enrobed with the film of thepresent invention may contain one or more active agents. The term“active agent” is used herein in a broad sense and may encompass anymaterial that can be carried by or entrained in the system. For example,the active agent can be a pharmaceutical, nutraceutical, vitamin,dietary supplement, nutrient, oral care agent, herb, foodstuff,dyestuff, nutritional, mineral, supplement, or favoring agent or thelike and combinations thereof.

Suitable pharmaceuticals include analgesics, anti-inflammatory agents,antiarthritics, anesthetics, antihistamines, antitussives, antibiotics,anti-infective agents, antivirals, anticoagulants, antidepressants,antidiabetic agents, antiemetics, antiflatulents, antifungals,antispasmodics, appetite suppressants, bronchodilators, cardiovascularagents, central nervous system agents, central nervous systemstimulants, decongestants, diuretics, expectorants, gastrointestinalagents, migraine preparations, motion sickness products, mucolytics,muscle relaxants, osteoporosis preparations, polydimethylsiloxanes,respiratory agents, sleep-aids, urinary tract agents and mixturesthereof.

Suitable oral care agents include breath fresheners, tooth whiteners,antimicrobial agents, tooth mineralizers, tooth decay inhibitors,topical anesthetics, mucoprotectants, and the like.

Suitable flavorants include menthol, peppermint, mint flavors, fruitflavors, chocolate, vanilla, bubblegum flavors, coffee flavors, liqueurflavors and combinations and the like.

Examples of suitable gastrointestinal agents include antacids such ascalcium carbonate, magnesium hydroxide, magnesium oxide, magnesiumcarbonate, aluminum hydroxide, sodium bicarbonate, dihydroxyaluminumsodium carbonate; stimulant laxatives, such as bisacodyl, cascarasagrada, danthron, senna, phenolphthalein, aloe, castor oil, ricinoleicacid, and dehydrocholic acid, and mixtures thereof; H2 receptorantagonists, such as famotadine, ranitidine, cimetadine, nizatidine;proton pump inhibitors such as omeprazole or lansoprazole;gastrointestinal cytoprotectives, such as sucraflate and misoprostol;gastrointestinal prokinetics, such as prucalopride, antibiotics for H.pylori, such as clarithromycin, amoxicillin, tetracycline, andmetronidazole; antidiarrheals, such as diphenoxylate and loperamide;glycopyrrolate; antiemetics, such as ondansetron, analgesics, such asmesalamine.

In one embodiment, the active agent may be selected from bisacodyl,famotadine, ranitidine, cimetidine, prucalopride, diphenoxylate,loperamide, lactase, mesalamine, bismuth, antacids, and pharmaceuticallyacceptable salts, esters, isomers, and mixtures thereof.

In another embodiment, the active agent may be selected fromacetaminophen, acetyl salicylic acid, ibuprofen, naproxen, ketoprofen,flurbiprofen, diclofenac, cyclobenzaprine, meloxicam, rofecoxib,celecoxib, and pharmaceutically acceptable salts, esters, isomers, andmixtures thereof.

In another embodiment, the active agent may be selected frompseudoephedrine, phenylpropanolamine, chlorpheniramine,dextromethorphan, diphenhydramine, astemizole, terfenadine,fexofenadine, loratadine, cetirizine, mixtures thereof andpharmaceutically acceptable salts, esters, isomers, and mixturesthereof.

Examples of suitable polydimethylsiloxanes, which include, but are notlimited to dimethicone and simethicone, are those disclosed in U.S. Pat.Nos. 4,906,478, 5,275,822, and 6,103,260, the contents of each isexpressly incorporated herein by reference. As used herein, the term“simethicone” refers to the broader class of polydimethylsiloxanes,including but not limited to simethicone and dimethicone.

The active ingredient(s) is present in the dosage form in atherapeutically effective amount, which is an amount that produces thedesired therapeutic response upon oral administration and can be readilydetermined by one skilled in the art. In determining such amounts, theparticular active ingredient being administered, the bioavailabilitycharacteristics of the active ingredient, the dose regime, the age andweight of the patient, and other factors must be considered, as known inthe art. Preferably, the dosage form comprises at least about 85 weightpercent of the active ingredient. In one preferred embodiment, the corecomprises at least about 85 weight percent of the active ingredient.

If the active ingredient has an objectionable taste, and the dosage formis intended to be chewed or disintegrated in the mouth prior toswallowing, the active ingredient may be coated with a taste maskingcoating, as known in the art. Examples of suitable taste maskingcoatings are described in U.S. Pat. No. 4,851,226, U.S. Pat. No.5,075,114 and U.S. Pat. No. 5,489,436. Commercially available tastemasked active ingredients may also be employed. For example,acetaminophen particles which are encapsulated with ethylcellulose orother polymers by a coaccervation process may be used in the presentinvention. Coaccervation-encapsulated acetaminophen may be purchasedcommercially from Eurand America, Inc. Vandalia, Ohio, or from CircaInc., Dayton, Ohio.

Suitable excipients include fillers, binders, disintegrants, lubricants,glidants, and the like.

Suitable fillers include water-soluble compressible carbohydrates suchas sugars, which include dextrose, sucrose, maltose, and lactose,sugar-alcohols, which include mannitol, sorbitol, maltitol, xylitol,starch hydrolysates, which include dextrins, and maltodextrins, and thelike, water insoluble plasticly deforming materials such asmicrocrystalline cellulose or other cellulosic derivatives,water-insoluble brittle fracture materials such as dicalcium phosphate,tricalcium phosphate and the like and mixtures thereof.

Suitable binders include dry binders such as polyvinyl pyrrolidone,hydroxypropylmethylcellulose, and the like; wet binders such aswater-soluble polymers, including hydrocolloids such as alginates, agar,guar gum, locust bean, carrageenan, tara, gum arabic, tragacanth,pectin, xanthan, gellan, maltodextrin, galactomannan, pusstulan,laminarin, scleroglucan, gum arabic, inulin, pectin, whelan, rhamsan,zooglan, methylan, chitin, cyclodextrin, chitosan, polyvinylpyrrolidone, cellulosics, starches, and the like; and derivatives andmixtures thereof.

Suitable disintegrants include sodium starch glycolate, cross-linkedpolyvinylpyrrolidone, cross-linked carboxymethylcellulose, starches,microcrystalline cellulose, and the like.

Suitable lubricants include long chain fatty acids and their salts, suchas magnesium stearate and stearic acid, talc, and waxes. Suitableglidants include colloidal silicon dioxide, and the like.

The dosage form of this invention may also incorporate pharmaceuticallyrd acceptable adjuvants, including, for example, preservatives,sweeteners such as aspartame, acesulfame potassium, sucralose, andsaccharin; flavors, antioxidants, surfactants, and coloring agents.

In one embodiment, the dosage forms comprising cores enrobed with thefilms of the present invention provided for immediate release of theactive ingredient, i.e. the dissolution of the dosage form conformed toUSP specifications for immediate release tablets containing theparticular active ingredient employed. For example, for acetaminophentablets, USP 24 specifies that in pH 5.8 phosphate buffer, using USPapparatus 2 (paddles) at 50 rpm, at least 80% of the acetaminophencontained in the dosage form is released therefrom within 30 minutesafter dosing, and for ibuprofen tablets, USP 24 specifies that in pH 7.2phosphate buffer, using USP apparatus 2 (paddles) at 50 rpm, at least80% of the ibuprofen contained in the dosage form is released therefromwithin 60 minutes after dosing. See USP 24, 2000 Version, 19-20 and 856(1999).

It will be understood that the embodiments described hereinabove aremerely exemplary and that a person skilled in the art may make manyvariations and modifications without departing from the spirit and scopeof the present invention. All such variations and modifications areintended to be included within the scope of the invention.

1. A process for enrobing a core comprising: providing a coating formedfrom at least one film having a thickness and a transition line segmentbetween visually distinct portions thereof that lie on opposite sides ofthe transition line, wherein each of said portions has a visualdistinction that substantially traverses the film thickness; andcovering at least a portion of an outer surface of the core with said atleast one film such that a film seam is formed which lies substantiallyin a first reference plane, which passes through the core, and such thatsaid transition line segment lies substantially in a second referenceplane, which passes through the core and intersects said first referenceplane, wherein said first reference plane is not congruent with saidsecond reference plane.
 2. The process according to claim 1, whereinsaid at least one film includes a first film having a first transitionline segment between visually distinct portions thereof and a secondfilm having a second transition line segment between visually distinctportions thereof.
 3. The process according to claim 2, furthercomprising: covering a first portion of said outer surface of the corewith said first film such that said first transition line segment liessubstantially in said second reference plane; and covering a secondportion of said outer surface of the core with said second film suchthat said second transition line segment lies substantially in saidsecond reference plane.
 4. The process according to claim 3, whereinsaid first and second transition line segments cooperate to form atransition line on said coating.
 5. The process according to claim 4,wherein said first film has a first portion lying on one side of saidfirst transition line segment and a second portion lying on an oppositeside of said first transition line segment, said first and secondportions of said first film being visually distinct from each other, andsaid second film has a first portion lying on one side of said secondtransition line segment and a second portion lying on an opposite sideof said second transition line segment, said first and second portionsof said second film being visually distinct from each other.
 6. Theprocess according to claim 5, wherein said first portion of said firstfilm has a first visual appearance, said second portion of said firstfilm has a second visual appearance, said first portion of said secondfilm has a third visual appearance and said second portion of saidsecond film has a fourth visual appearance.
 7. The process according toclaim 6, wherein said first visual appearance of said first portion ofsaid first film is substantially the same as said third visualappearance of said first portion of said second film, and second visualappearance of said second portion of said first film is substantiallythe same as said fourth visual appearance of said second portion of saidsecond film, said first and third visual appearances being differentfrom said second and fourth visual appearances.
 8. The process accordingto claim 7, further comprising: orienting said first and second films,prior to covering the outer surface of the core, such that said firstportions of said first and second films lie on one side of saidtransition line of said coating, whereby said first portions areadjacent to one another and positioned on opposite sides of said filmseam, and said second portions of said first and second films lie on anopposite side of said transition line of said coating, whereby saidsecond portions are adjacent to one another and positioned on oppositesides of said film seam.
 9. The process according to claim 8, whereinsaid first and third visual appearances are characterized by a firstcolor and said second and fourth visual appearances are characterized bya second color that is different from said first color, whereby saidcoating of the enrobed core includes at least two differently coloredportions.
 10. The process according to claim 7, further comprising:orienting said first and second films, prior to covering the outersurface of the core, such that said first portion of said first film andsaid second portion of said second film lie on one side of saidtransition line, whereby said first portion of said first film and saidsecond portion of said second film are adjacent to one another andpositioned on opposite sides of said film seam, and said second portionof said first film and said first portion of said second film lie on anopposite side of said transition line, whereby said second portion ofsaid first film and said first portion of said second film are adjacentto one another and positioned on opposite sides of said film seam. 11.The process according to claim 10, wherein said first and third visualappearances are characterized by a first color and said second andfourth visual appearances are characterized by a second color that isdifferent from said first color, whereby said coating of the enrobedcore includes at least four colored portions that are alternatelyarranged on said coating.
 12. The process according to claim 3, whereineach of said first and second films includes free edges.
 13. The processaccording to claim 12, wherein said free edges are slightly spaced apartfrom one another, thereby forming said film seam of said coating. 14.The process according to claim 12, further comprising: sealing said freeedges of said first and second films together, thereby forming said filmseam of said coating.
 15. The process according to claim 14, whereinsaid free edges of said first and second films abut one another to formsaid film seam of said coating.
 16. The process according to claim 14,wherein said free edges of said first and second films overlap with oneanother to form said film seam of said coating.
 17. The processaccording to claim 3, wherein said transition line of said coating iscurvilinear.
 18. The process according to claim 1, wherein saidtransition line segment is curvilinear.
 19. The process according toclaim 1, wherein the core is a tablet.